Sample records for oncology drugs advisory
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75 FR 81283 - Oncologic Drugs Advisory Committee; Cancellation
2010-12-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Oncologic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Oncologic Drugs Advisory Committee scheduled for February 9, 2011, is...
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77 FR 63839 - Oncologic Drugs Advisory Committee; Cancellation
2012-10-17
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Oncologic Drugs Advisory Committee Meeting scheduled for November 8, 2012, is...
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2011-09-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. General...
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2013-02-25
...] Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory Committee... be open to the public. Name of Committees: Medical Imaging Drugs Advisory Committee and the Oncologic... Special Medical Programs. [FR Doc. 2013-04141 Filed 2-22-13; 8:45 am] BILLING CODE 4160-01-P ...
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2010-10-29
...] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. General... or, are in late stage development for an adult oncology indication. The subcommittee will consider...
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2012-09-17
...] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. General... that are in development for an adult oncology indication. The subcommittee will consider and discuss...
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2011-10-05
...] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. General... adult oncology indication, or in late stage development in pediatric patients with cancer. The...
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2013-10-23
...] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. General... oncology indications. The subcommittee will consider and discuss issues relating to the development of each...
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2013-10-23
...] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... the public. Name of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory... measures in the pediatric development plans of oncology products. The half-day session will provide an...
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77 FR 31025 - Oncologic Drugs Advisory Committee; Notice of Meeting
2012-05-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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77 FR 58399 - Oncologic Drugs Advisory Committee; Notice of Meeting
2012-09-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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78 FR 13348 - Oncologic Drugs Advisory Committee; Notice of Meeting
2013-02-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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77 FR 32125 - Oncologic Drugs Advisory Committee; Notice of Meeting
2012-05-31
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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75 FR 9419 - Oncologic Drugs Advisory Committee; Notice of Meeting
2010-03-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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78 FR 48690 - Oncologic Drugs Advisory Committee; Notice of Meeting
2013-08-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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77 FR 5813 - Oncologic Drugs Advisory Committee; Notice of Meeting
2012-02-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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76 FR 82309 - Oncologic Drugs Advisory Committee; Notice of Meeting
2011-12-30
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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76 FR 11489 - Oncologic Drugs Advisory Committee; Notice of Meeting
2011-03-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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77 FR 25184 - Oncologic Drugs Advisory Committee; Notice of Meeting
2012-04-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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76 FR 44595 - Oncologic Drugs Advisory Committee; Notice of Meeting
2011-07-26
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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76 FR 82310 - Oncologic Drugs Advisory Committee; Notice of Meeting
2011-12-30
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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76 FR 65736 - Oncologic Drugs Advisory Committee; Notice of Meeting
2011-10-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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75 FR 75680 - Oncologic Drugs Advisory Committee; Notice of Meeting
2010-12-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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75 FR 71450 - Oncologic Drugs Advisory Committee; Amendment of Notice
2010-11-23
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Oncologic Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an amendment to the notice of a...
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77 FR 37911 - Oncologic Drugs Advisory Committee; Amendment of Notice
2012-06-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the...
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76 FR 45402 - Advisory Committee; Medical Imaging Drugs Advisory Committee; Re-Establishment
2011-07-29
.... FDA-2010-N-0002] Advisory Committee; Medical Imaging Drugs Advisory Committee; Re- Establishment... (FDA) is announcing the re- establishment of the Medical Imaging Drugs Advisory Committee in FDA's Center for Drug Evaluation and Research. This rule amends the current language for the Medical Imaging...
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Advisory Board on Alcoholism and Drug Abuse
State Employees Advisory Board on Alcoholism and Drug Abuse DHSS State of Alaska Home Divisions and ; Advisory Board on Alcoholism and Drug Abuse Page Content Alison Kulas Executive Director If you, a family Kulas Begins Tenure as Executive Director The Advisory Board on Alcoholism and Drug Abuse, The Alaska
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2012-11-21
... Alcohol Abuse and Alcoholism, National Advisory Council on Drug Abuse, and National Cancer Advisory Board... Advisory Council on Alcohol Abuse and Alcoholism, National Advisory Council on Drug Abuse, and National...: National Advisory Council on Alcohol Abuse and Alcoholism, National Advisory Council on Drug Abuse, and...
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Maeda, Hideki; Kurokawa, Tatsuo
2015-12-01
This study exhaustively and historically investigated the status of drug lag for oncology drugs approved in Japan. We comprehensively investigated oncology drugs approved in Japan between April 2001 and July 2014, using publicly available information. We also examined changes in the status of drug lag between Japan and the United States, as well as factors influencing drug lag. This study included 120 applications for approval of oncology drugs in Japan. The median difference over a 13-year period in the approval date between the United States and Japan was 875 days (29.2 months). This figure peaked in 2002, and showed a tendency to decline gradually each year thereafter. In 2014, the median approval lag was 281 days (9.4 months). Multiple regression analysis identified the following potential factors that reduce drug lag: "Japan's participation in global clinical trials"; "bridging strategies"; "designation of priority review in Japan"; and "molecularly targeted drugs". From 2001 to 2014, molecularly targeted drugs emerged as the predominant oncology drug, and the method of development has changed from full development in Japan or bridging strategy to global simultaneous development by Japan's taking part in global clinical trials. In line with these changes, the drug lag between the United States and Japan has significantly reduced to less than 1 year.
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2013-04-04
... Management Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice... of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management... Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee...
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78 FR 17413 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2013-03-21
...] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... rescheduled due to the postponement of the March 7, 2013, Pulmonary-Allergy Drugs Advisory Committee meeting due to unanticipated weather conditions. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee...
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75 FR 8377 - Pulmonary-Allergy Drugs Advisory Committee; Amendment of Notice
2010-02-24
...] Pulmonary-Allergy Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS... of a meeting of the Pulmonary-Allergy Drugs Advisory Committee. This meeting was announced in the... February 2, 2010, FDA announced that a meeting of the Pulmonary-Allergy Drugs Advisory Committee would be...
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Factors associated with prescribing restriction on oncology formulary drugs in Malaysia.
Fatokun, Omotayo; Olawepo, Michael N
2016-10-01
Background Drugs listed on formularies are often subjected to a variety of utilization restriction measures. However, the degree of restriction is influenced by multiple factors, including the characteristics and attributes of the listed drugs. Objective To identify the factors that are associated with the levels of prescribing restriction on oncology formulary drugs in Malaysia. Setting Oncology formulary in Malaysia. Method The Malaysia Drug Code assigned to each of the drug products on the Malaysia Ministry of Health (MOH) drug formulary was used to identify oncology drugs belonging to WHO ATC class L (antineoplastic and immunomodulating agents). Main outcome measures Categories of prescribing restrictions, therapeutic class, drug type, administration mode, number of sources and the post-approval use period. Results Oncology drugs having a shorter post-approval use period (p Malaysia MOH drug formulary.
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2010-09-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee and the Drug Safety... and Central Nervous System Drugs Advisory Committee and the Drug Safety and Risk Management Advisory...
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77 FR 50702 - Cardiovascular and Renal Drugs Advisory Committee; Cancellation
2012-08-22
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Cardiovascular and Renal Drugs Advisory Committee scheduled for...
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78 FR 57166 - Antiviral Drugs Advisory Committee; Notice of Meeting
2013-09-17
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Antiviral Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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75 FR 16151 - Antiviral Drugs Advisory Committee; Notice of Meeting
2010-03-31
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Antiviral Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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76 FR 62418 - Antiviral Drugs Advisory Committee; Notice of Meeting
2011-10-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Antiviral Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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2010-03-08
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory... Drug Safety and Risk Management Advisory Committee. General Function of the Committees: To provide...
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77 FR 65000 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting
2012-10-24
...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... Use (ETASU) before CDER's Drug Safety and Risk Management Advisory Committee (DSaRM). The Agency plans...
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78 FR 30929 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting
2013-05-23
...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... (REMS) with elements to assure safe use (ETASU) before its Drug Safety and Risk Management Advisory...
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78 FR 734 - Medical Imaging Drugs Advisory Committee; Notice of Meeting
2013-01-04
...] Medical Imaging Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Medical Imaging Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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75 FR 9420 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2010-03-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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76 FR 29766 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2011-05-23
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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77 FR 4566 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2012-01-30
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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77 FR 69635 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2012-11-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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75 FR 5334 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2010-02-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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75 FR 82031 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2010-12-29
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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77 FR 74486 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2012-12-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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77 FR 69636 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2012-11-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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75 FR 5333 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2010-02-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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78 FR 46976 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2013-08-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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2012-02-28
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Joint Meeting of the Anti-Infective Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public...
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International Nuclear Information System (INIS)
Rosenfeldt, Hans; Kropp, Timothy; Benson, Kimberly; Ricci, M. Stacey; McGuinn, W. David; Verbois, S. Leigh
2010-01-01
The drug development of new anti-cancer agents is streamlined in response to the urgency of bringing effective drugs to market for patients with limited life expectancy. FDA's regulation of oncology drugs has evolved from the practices set forth in Arnold Lehman's seminal work published in the 1950s through the current drafting of a new International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) safety guidance for anti-cancer drug nonclinical evaluations. The ICH combines the efforts of the regulatory authorities of Europe, Japan, and the United States and the pharmaceutical industry from these three regions to streamline the scientific and technical aspects of drug development. The recent development of new oncology drug classes with novel mechanisms of action has improved survival rates for some cancers but also brings new challenges for safety evaluation. Here we present the legacy of Lehman and colleagues in the context of past and present oncology drug development practices and focus on some of the current issues at the center of an evolving harmonization process that will generate a new safety guidance for oncology drugs, ICH S9. The purpose of this new guidance will be to facilitate oncology drug development on a global scale by standardizing regional safety requirements.
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2011-09-23
...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the...., [[Page 59143
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Observational study of drug-drug interactions in oncological inpatients
Directory of Open Access Journals (Sweden)
María Sacramento Díaz-Carrasco
2018-01-01
Full Text Available Objective: To determine the prevalence of potential clinically relevant drug- drug interactions in adult oncological inpatients, as well as to describe the most frequent interactions. A standard database was used. Method: An observational, transversal, and descriptive study including patients admitted to the Oncology Service of a reference hospital. All prescriptions were collected twice a week during a month. They were analysed using Lexicomp® database, recording all interactions classified with a level of risk: C, D or X. Results: A total of 1 850 drug-drug interactions were detected in 218 treatments. The prevalence of treatments with at least one clinically relevant interaction was 95%, being 94.5% for those at level C and 26.1% for levels D and X. The drugs most commonly involved in the interactions detected were opioid analgesics, antipsychotics (butyrophenones, benzodiazepines, pyrazolones, glucocorticoids and heparins, whereas interactions with antineoplastics were minimal, highlighting those related to paclitaxel and between metamizole and various antineoplastics. Conclusions: The prevalence of clinically relevant drug-drug interactions rate was very high, highlighting the high risk percentage of them related to level of risk X. Due to the frequency of onset and potential severity, highlighted the concomitant use of central nervous system depressants drugs with risk of respiratory depression, the risk of onset of anticholinergic symptoms when combining morphine or haloperidol with butylscopolamine, ipratropium bromide or dexchlorpheniramine and the multiple interactions involving metamizole.
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Adkins, Elizabeth M; Nicholson, Lindsay; Floyd, David; Ratcliffe, Mark; Chevrou-Severac, Helene
2017-01-01
Orphan drugs (ODs) are intended for the diagnosis, prevention, or treatment of rare diseases. Many cancer subtypes, including all childhood cancers, are defined as rare diseases, and over one-third of ODs are now intended to treat oncology indications. However, market access for oncology ODs is becoming increasingly challenging; ODs are prone to significant uncertainty around their cost-effectiveness, while payers must balance the need for these vital innovations with growing sensitivity to rising costs. The objective of this review was to evaluate different mechanisms that have been introduced to facilitate patient access to oncology ODs in five different countries (Australia, Canada, England, France, and Sweden), using eight oncology ODs and non-orphan oncology drugs as examples of their application. A targeted literature review of health technology assessment (HTA) agency websites was undertaken to identify country-specific guidance and HTA documentation for recently evaluated oncology ODs and non-orphan oncology drugs. None of these countries were found to have explicit HTA criteria for the assessment of ODs, and therefore, oncology ODs are assessed through the usual HTA process. However, distinct and additional processes are adopted to facilitate access to oncology ODs. Review of eight case-study drugs showed that these additional assessment processes were rarely used, and decisions were largely driven by proving cost-effectiveness using standard incremental cost-effectiveness ratio (ICER) thresholds. The predominant implication arising from this study is that application of standard HTA criteria to oncology ODs in many countries fails to take into account any uncertainties around their clinical- and cost-effectiveness, resulting in disparities in HTA reimbursement decisions based on differences in addressing or accepting uncertainty. In order to address this issue, HTA agencies should adopt a more flexible approach to cost-effectiveness, as typified by the
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The Medicaid Rebate: Changes in Oncology Drug Prices After the Affordable Care Act.
Bonakdar Tehrani, Ali; Carroll, Norman V
2017-08-01
Prescription drug spending is a significant component of Medicaid total expenditures. The Affordable Care Act (ACA) includes a provision that increases the Medicaid rebate for both brand-name and generic drugs. This study examines the extent to which oncology drug prices changed after the increase in the Medicaid rebate in 2010. A pre-post study design was used to evaluate the correlation between the Medicaid rebate increase and oncology drug prices after 2010 using 2006-2013 State Drug Utilization Data. The results show that the average annual price of top-selling cancer drugs in 2006, adjusted for inflation and secular changes in drug prices, have increased by US$154 and US$235 for branded and competitive brand drugs, respectively, following the 2010 ACA; however, generic oncology drug prices showed no significant changes. The findings from this study indicate that oncology drug prices have increased after the 2010 ACA, and suggest that pharmaceutical companies may have increased their drug prices to offset increases in Medicaid rebates.
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77 FR 12062 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2012-02-28
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... of Committee: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee...
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2011-06-23
... Alcohol Abuse and Alcoholism and National Advisory Council on Drug Abuse; Notice of Joint Meeting Pursuant... given of a joint meeting of the National Advisory Council on Alcohol Abuse and Alcoholism and the National Institute on Drug Abuse. The meeting will be open to the public as indicated below, with...
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77 FR 43093 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2012-07-23
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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78 FR 38717 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2013-06-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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75 FR 35496 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2010-06-22
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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77 FR 43600 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2012-07-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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75 FR 1395 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2010-01-11
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0664] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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78 FR 36787 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2013-06-19
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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75 FR 52762 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2010-08-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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75 FR 30839 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2010-06-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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76 FR 82310 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2011-12-30
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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76 FR 39404 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2011-07-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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The Value of Specialty Oncology Drugs
Goldman, Dana P; Jena, Anupam B; Lakdawalla, Darius N; Malin, Jennifer L; Malkin, Jesse D; Sun, Eric
2010-01-01
Objective To estimate patients' elasticity of demand, willingness to pay, and consumer surplus for five high-cost specialty medications treating metastatic disease or hematologic malignancies. Data Source/Study Setting Claims data from 71 private health plans from 1997 to 2005. Study Design This is a revealed preference analysis of the demand for specialty drugs among cancer patients. We exploit differences in plan generosity to examine how utilization of specialty oncology drugs varies with patient out-of-pocket costs. Data Collection/Extraction Methods We extracted key variables from administrative health insurance claims records. Principal Findings A 25 percent reduction in out-of-pocket costs leads to a 5 percent increase in the probability that a patient initiates specialty cancer drug therapy. Among patients who initiate, a 25 percent reduction in out-of-pocket costs reduces the number of treatments (claims) by 1–3 percent, depending on the drug. On average, the value of these drugs to patients who use them is about four times the total cost paid by the patient and his or her insurer, although this ratio may be lower for oral specialty therapies. Conclusions The decision to initiate therapy with specialty oncology drugs is responsive to price, but not highly so. Among patients who initiate therapy, the amount of treatment is equally responsive. The drugs we examine are highly valued by patients in excess of their total costs, although oral agents warrant further scrutiny as copayments increase. PMID:19878344
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2011-07-11
...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the... East, Adelphi, MD. The conference center telephone number is: 301 985-7300. Contact Person: Kalyani...
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75 FR 70933 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2010-11-19
...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... of Committee: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committees... appropriate clinical study design for thromboxane receptor antagonists for prevention of cardiovascular events...
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76 FR 30176 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting
2011-05-24
... committee will discuss biologics license application (BLA) 125387, aflibercept ophthalmic solution, proposed...] Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration...: Dermatologic and Ophthalmic Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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2013-01-14
...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the... before February 7, 2013. Time allotted for each presentation may be limited. If the number of registrants...
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2011-09-23
...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the..., Adelphi, MD. The conference center telephone number is 301-985-7300. Contact Person: Kalyani Bhatt, Center...
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78 FR 76307 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2013-12-17
...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and... combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization. FDA intends...
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2013-03-14
...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the... presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably...
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78 FR 76308 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2013-12-17
...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and..., Inc., for the proposed indication to reduce the risk of thrombotic cardiovascular events in patients...
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75 FR 57474 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2010-09-21
...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and... analyses of the TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy) study of ARANESP...
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77 FR 21982 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2012-04-12
...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...., to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS...
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A drug's life: the pathway to drug approval.
Keng, Michael K; Wenzell, Candice M; Sekeres, Mikkael A
2013-10-01
In the United States, drugs and medical devices are regulated by the US Food and Drug Administration (FDA). A drug must undergo rigorous testing prior to marketing to and medical use by the general public. The FDA grants marketing approval for drug products based on a comprehensive review of safety and efficacy data. This review article explains the history behind the establishment of the FDA and examines the historical legislation and approval processes for drugs, specifically in the fields of medical oncology and hematology. The agents imatinib (Gleevec, Novartis) and decitabine (Dacogen, Eisai) are used to illustrate both the current FDA regulatory process-specifically the orphan drug designation and accelerated approval process-and why decitabine failed to gain an indication for acute myeloid leukemia. The purpose and construct of the Oncologic Drugs Advisory Committee are also discussed, along with examples of 2 renal cell cancer drugs-axitinib (Inlyta, Pfizer) and tivozanib-that used progression-free survival as an endpoint. Regulatory approval of oncology drugs is the cornerstone of the development of new treatment agents and modalities, which lead to improvements in the standard of cancer care. The future landscape of drug development and regulatory approval will be influenced by the new breakthrough therapy designation, and choice of drug will be guided by genomic insights.
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75 FR 23782 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting
2010-05-04
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide...
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Oncology drug discovery: planning a turnaround.
Toniatti, Carlo; Jones, Philip; Graham, Hilary; Pagliara, Bruno; Draetta, Giulio
2014-04-01
We have made remarkable progress in our understanding of the pathophysiology of cancer. This improved understanding has resulted in increasingly effective targeted therapies that are better tolerated than conventional cytotoxic agents and even curative in some patients. Unfortunately, the success rate of drug approval has been limited, and therapeutic improvements have been marginal, with too few exceptions. In this article, we review the current approach to oncology drug discovery and development, identify areas in need of improvement, and propose strategies to improve patient outcomes. We also suggest future directions that may improve the quality of preclinical and early clinical drug evaluation, which could lead to higher approval rates of anticancer drugs.
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77 FR 75176 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting
2012-12-19
...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug... being rescheduled due to the postponement of the October 29-30, 2012, Drug Safety and Risk Management... Committee: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide...
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2010-04-06
...] Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory... Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. This meeting was... Drug Safety and Risk Management Advisory Committee would be held on May 12, 2010. On page 10490, in the...
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76 FR 44595 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
2011-07-26
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug... Committee: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee...
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75 FR 12768 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
2010-03-17
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...
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78 FR 20328 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
2013-04-04
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...
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78 FR 63478 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
2013-10-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...
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75 FR 36428 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
2010-06-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...
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77 FR 20037 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
2012-04-03
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...
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76 FR 3912 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
2011-01-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...
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75 FR 17417 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
2010-04-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...
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78 FR 63481 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
2013-10-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...
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Bridging Adult Experience to Pediatrics in Oncology Drug Development.
Leong, Ruby; Zhao, Hong; Reaman, Gregory; Liu, Qi; Wang, Yaning; Stewart, Clinton F; Burckart, Gilbert
2017-10-01
Pediatric drug development in the United States has grown under the current regulations made permanent by the Food and Drug Administration Safety and Innovation Act of 2012. Over 1200 pediatric studies have now been submitted to the US FDA, but there is still a high rate of failure to obtain pediatric labeling for the indication pursued. Pediatric oncology represents special problems in that the disease is most often dissimilar to any cancer found in the adult population. Therefore, the development of drug dosing in pediatric oncology patients represents a special challenge. Potential approaches to pediatric dosing in oncology patients include extrapolation of efficacy from adult studies in those few cases where the disease is similar, inclusion of adolescent patients in adult trials when possible, and bridging the adult dose to the pediatric dose. An analysis of the recommended phase 2 dose for 40 molecularly targeted agents in pediatric patients provides some insight into current practices. Increased knowledge of tumor biology and efforts to identify and validate molecular targets and genetic abnormalities that drive childhood cancers can lead to increased opportunities for precision medicine in the treatment of pediatric cancers. © 2017, The American College of Clinical Pharmacology.
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75 FR 75681 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
2010-12-06
...] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...) and/or abnormal vascularity (abnormal blood supply and circulation) of the central nervous system. The...
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Characteristics of potential drug-related problems among oncology patients
Bulsink, Arjan; Imholz, Alex L. T.; Brouwers, Jacobus R. B. J.; Jansman, Frank G. A.
Background Oncology patients are more at risk for drug related problems because of treatment with (combinations of) anticancer drugs, as they have a higher risk for organ failure or altered metabolism with progression of their disease. Objective The aim of this study was to characterize and to
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Outlook of the process of storage of oncology drugs from the logistic operator in Colombia
Directory of Open Access Journals (Sweden)
Pedro Vicente Sánchez-Calvera
2014-05-01
Full Text Available This article mainly on the problem of storage of oncology drugs, which is an important element in the supply chain, applied in the context of warehouse management of oncology drugs, in the logistics operator and providers of health services institutions (IPS for its acronym in Spanish of Bogotá DC and in the contex of a macro project "Methodological proposal for the definition of policies , rules of negotation and coordination in supply management of oncology drugs in Colombia," funded by Colciencias and the Universidad Nacional of Colombia. This article presents the current situation of oncology drugs, marking a characterization, diagnosis and identification and startegies evaluated under different scenarios. Finally, it is presented a proposal of improvement applied tranversely to storage processes including labels such as just in Time and the application of information and communication technologies (ICT.
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2010-06-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice...
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Budget impact analysis of drugs for ultra-orphan non-oncological diseases in Europe.
Schlander, Michael; Adarkwah, Charles Christian; Gandjour, Afschin
2015-02-01
Ultra-orphan diseases (UODs) have been defined by a prevalence of less than 1 per 50,000 persons. However, little is known about budget impact of ultra-orphan drugs. For analysis, the budget impact analysis (BIA) had a time horizon of 10 years (2012-2021) and a pan-European payer's perspective, based on prevalence data for UODs for which patented drugs are available and/or for which drugs are in clinical development. A total of 18 drugs under patent protection or orphan drug designation for non-oncological UODs were identified. Furthermore, 29 ultra-orphan drugs for non-oncological diseases under development that have the potential of reaching the market by 2021 were found. Total budget impact over 10 years was estimated to be €15,660 and €4965 million for approved and pipeline ultra-orphan drugs, respectively (total: €20,625 million). The analysis does not support concerns regarding an uncontrolled growth in expenditures for drugs for UODs.
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76 FR 70462 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting
2011-11-14
...] Advisory Committee for Reproductive Health Drugs; Notice of Meeting AGENCY: Food and Drug Administration... Committee for Reproductive Health Drugs. General Function of the Committee: To provide advice and... be limited. If the number of registrants requesting to speak is greater than can be reasonably...
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78 FR 734 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting
2013-01-04
...] Advisory Committee for Reproductive Health Drugs; Notice of Meeting AGENCY: Food and Drug Administration... Committee for Reproductive Health Drugs. General Function of the Committee: To provide advice and... limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated...
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2010-04-22
...] (formerly Docket No. 02D-0049) Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff: Public Availability of Advisory Committee Members... and Drug Administration Amendments Act of 2007, Public Law No. 110-85), and section 701 (21 U.S.C. 371...
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Directory of Open Access Journals (Sweden)
Mitja Kos
2007-09-01
Full Text Available Background: The aim of the present study is to analyze the admission of anticancer drugs to the Slovenian healthcare system, and to evaluate patients’ accessibility to these medications.Methods: Admission and accessibility to anticancer drugs was evaluated by analysing: differences in registration time among USA, selected member states of EU, and Slovenia; time from the registration to the first use in Slovenia; differences between the first use in Slovenia and the first use in selected member states of EU and by analysing the market of oncology drugs. The study included drugs of the ATC groups such as Antitumor medications (cytostatics (ATC = L01 and Endocrine treatment (ATC = L02 that were used in Slovenia for the first time between 1999 to 2005. Registration data for Slovenia and EU was obtained from the registration documention of selected drugs at the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia, and the European Agency for the Evaluation of Medicinal Products (EMEA. Registration data for USA was obtained from the registration documention of selected drugs at the Food and Drug Administration (FDA. The information upon the first use of drugs in Slovenia was acquired from the PharMIS system, and the information upon the first use of drugs in selected member states of EU was obtained from the study on patients’ access to oncology drugs by Nils Wilking and Bengt Jönsson, performed from 2005. Data for the market analysis of oncology drugs was obtained from the PharMIS system.Results: In previous years a delay in registration time between Slovenia and compared states was present for some oncology drugs. Along with the acceptance of Slovenia as a new member state of EU, on 1st May 2004, registration process in Slovenia became a part of the registration system of the European Agency for the Evaluation of Medicinal Products (EMEA. Majority of drugs had a time difference between the registration and the first use
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Paving roads for new drugs in oncology.
Zaenker, Kurt S; Entschladen, Frank
2009-06-01
Low productivity and the escalating costs of drug development have been well documented over the past years. A fraction of new pre-clinical compounds successfully pass experimental test batteries, and less than 10% of these compounds that enter clinical trials ultimately make it to the market. These challenges in the "critical path" of drug development will be discussed for drugs in the field of oncology, regarding the i) the impact of FDA and EMEA guidelines, and ii) microdosing studies/phase 0 trials before a drug enters phase I to III, to inform drug development, compressing drug development timelines and decision-making for continuation into clinical trials. Moreover, this review should embark on i) how to find new key molecules involved in life-and-death decision of a cell, how ii) old drugs will have a revival for new indications, because of novel information for their mode of action, and iii) how the revolutionary advances - high-throughput technologies, gene therapy and the deciphering of the human genome - do have their potential to develop personalized therapy. Therapy has progressed from an age of administering herbal remedies and organ extracts to an era of meticulously planned drug discovery, when pharmaceutical industry was born in a Western understanding. The relevant patents are discussed.
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2011-10-14
...] Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and... Administration (FDA). The meeting will be open to the public. Name of Committees: Drug Safety and Risk Management... Safe Use (ETASU) before its Drug Safety and Risk Management Advisory Committee (DSaRM). On December 1...
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Crowdfunding drug development: the state of play in oncology and rare diseases.
Dragojlovic, Nick; Lynd, Larry D
2014-11-01
In this article, we present descriptive data on 125 crowdfunding campaigns aimed at financing research in oncology (including basic research, drug discovery, and clinical trials). We also describe five campaigns that have succeeded in raising substantial funds to support the development of treatments for ultrarare diseases. The data suggest that crowdfunding is a viable approach to supporting early proof-of-concept research that could allow researchers in oncology and rare diseases to succeed in traditional grant competitions or to attract private investment. The data also suggest that such an approach could become a valuable additional source of funding for early-stage innovators in the drug development arena. Copyright © 2014 Elsevier Ltd. All rights reserved.
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78 FR 76308 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2013-12-17
...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and... enter through Building 1. Contact Person: Kristina Toliver, Center for Drug Evaluation and Research... system atrophy, or pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic...
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International Nuclear Information System (INIS)
2013-01-01
The decree is about an adaptation of the integration of the national committee on oncologic o including representatives of the Faculty of Medicine of the University of the Republic and representatives of the National Board of Health and Honorary Commission to Fight Cancer that is proposed.Creating a Standing Advisory Group is also suggested
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Xu, Rong; Wang, QuanQiu
2015-06-01
Targeted anticancer drugs such as imatinib, trastuzumab and erlotinib dramatically improved treatment outcomes in cancer patients, however, these innovative agents are often associated with unexpected side effects. The pathophysiological mechanisms underlying these side effects are not well understood. The availability of a comprehensive knowledge base of side effects associated with targeted anticancer drugs has the potential to illuminate complex pathways underlying toxicities induced by these innovative drugs. While side effect association knowledge for targeted drugs exists in multiple heterogeneous data sources, published full-text oncological articles represent an important source of pivotal, investigational, and even failed trials in a variety of patient populations. In this study, we present an automatic process to extract targeted anticancer drug-associated side effects (drug-SE pairs) from a large number of high profile full-text oncological articles. We downloaded 13,855 full-text articles from the Journal of Oncology (JCO) published between 1983 and 2013. We developed text classification, relationship extraction, signaling filtering, and signal prioritization algorithms to extract drug-SE pairs from downloaded articles. We extracted a total of 26,264 drug-SE pairs with an average precision of 0.405, a recall of 0.899, and an F1 score of 0.465. We show that side effect knowledge from JCO articles is largely complementary to that from the US Food and Drug Administration (FDA) drug labels. Through integrative correlation analysis, we show that targeted drug-associated side effects positively correlate with their gene targets and disease indications. In conclusion, this unique database that we built from a large number of high-profile oncological articles could facilitate the development of computational models to understand toxic effects associated with targeted anticancer drugs. Copyright © 2015 Elsevier Inc. All rights reserved.
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Accelerated approval of oncology products: the food and drug administration experience.
Johnson, John R; Ning, Yang-Min; Farrell, Ann; Justice, Robert; Keegan, Patricia; Pazdur, Richard
2011-04-20
We reviewed the regulatory history of the accelerated approval process and the US Food and Drug Administration (FDA) experience with accelerated approval of oncology products from its initiation in December 11, 1992, to July 1, 2010. The accelerated approval regulations allowed accelerated approval of products to treat serious or life-threatening diseases based on surrogate endpoints that are reasonably likely to predict clinical benefit. Failure to complete postapproval trials to confirm clinical benefit with due diligence could result in removal of the accelerated approval indication from the market. From December 11, 1992, to July 1, 2010, the FDA granted accelerated approval to 35 oncology products for 47 new indications. Clinical benefit was confirmed in postapproval trials for 26 of the 47 new indications, resulting in conversion to regular approval. The median time between accelerated approval and regular approval of oncology products was 3.9 years (range = 0.8-12.6 years) and the mean time was 4.7 years, representing a substantial time savings in terms of earlier availability of drugs to cancer patients. Three new indications did not show clinical benefit when confirmatory postapproval trials were completed and were subsequently removed from the market or had restricted distribution plans implemented. Confirmatory trials were not completed for 14 new indications. The five longest intervals from receipt of accelerated approval to July 1, 2010, without completion of trials to confirm clinical benefit were 10.5, 6.4, 5.5, 5.5, and 4.7 years. The five longest intervals between accelerated approval and successful conversion to regular approval were 12.6, 9.7, 8.1, 7.5, and 7.4 years. Trials to confirm clinical benefit should be part of the drug development plan and should be in progress at the time of an application seeking accelerated approval to prevent an ineffective drug from remaining on the market for an unacceptable time.
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Evolution of health technology assessment: best practices of the pan-Canadian Oncology Drug Review
Directory of Open Access Journals (Sweden)
Rocchi A
2015-06-01
Full Text Available Angela Rocchi,1 Isabelle Chabot,2 Judith Glennie3 1Athena Research Inc., Burlington, ON, 2EvAccess Inc., Vaudreuil-Dorion, QC, 3JL Glennie Consulting Inc., Aurora, ON, Canada Background: In 2007, Canada chose to develop a separate and distinct path for oncology drug health technology assessment (HTA. In 2013, the decision was made to transfer the pan-Canadian Oncology Drug Review (pCODR to the Canadian Agency for Drugs and Technologies in Health (CADTH, to align the pCODR and CADTH Common Drug Review processes while building on the best practices of both. The objective of this research was to conduct an examination of the best practices established by the pCODR. Methods: A qualitative research approach was taken to assess the policies, processes, and practices of the pCODR, based on internationally accepted best practice “principles” in HTA, with a particular focus on stakeholder engagement. Publicly available information regarding the approach of the pCODR was used to gauge the agency's performance against these principles. In addition, stakeholder observations and real-world experiences were gathered through key informant interviews to be inclusive of perspectives from patient advocacy groups, provincial and/or cancer agency decision-makers, community and academic oncologists, industry, expert committee members, and health economists. Results: This analysis indicated that, through the pCODR, oncology stakeholders have had a voice in and have come to trust the quality and relevance of oncology HTA as a vital tool to ensure the best decisions for Canadians with cancer and their health care system. It could be expected that adoption of the principles and processes of the pCODR would bring a similar level of engagement and trust to other HTA organizations in Canada and elsewhere. Conclusion: The results of this research led to recommendations for improvement and potential extrapolation of these best practices to other HTA organizations
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Gnanasakthy, Ari; DeMuro, Carla; Clark, Marci; Haydysch, Emily; Ma, Esprit; Bonthapally, Vijayveer
2016-06-01
To review the use of patient-reported outcome (PRO) data in medical product labeling granted by the US Food and Drug Administration (FDA) for new molecular entities and biologic license applications by the FDA Office of Hematology and Oncology Products (OHOP) between January 2010 and December 2014, to elucidate challenges faced by OHOP for approving PRO labeling, and to understand challenges faced by drug manufacturers to include PRO end points in oncology clinical trials. FDA Drug Approval Reports by Month were reviewed to obtain the number of new molecular entities and biologic license applications approved from 2010 to 2014. Drugs approved by the FDA OHOP during this period were selected for further review, focusing on brand and generic name; approval date; applicant; indication; PRO labeling describing treatment benefit, measures, end point status, and significant results; FDA reviewer feedback on PRO end points; and study design of registration trials. First in class, priority review, fast track, orphan drug, or accelerated approval status was retrieved for selected oncology drugs from 2011 to 2014. Descriptive analyses were performed by using Microsoft Excel 2010. Of 160 drugs approved by the FDA (2010-2014), 40 were approved by OHOP. Three (7.5%) of the 40 received PRO-related labeling (abiraterone acetate, ruxolitinib phosphate, and crizotinib). Compared with nononcology drugs (2011-2014), oncology drugs were more likely to be orphan and first in class. The majority of oncology drug reviews by FDA were fast track, priority, or accelerated. Although symptoms and functional decrements are common among patients with cancer, PRO labeling is rare in the United States, likely because of logistical hurdles and oncology study design. Recent developments within the FDA OHOP to capture PROs in oncology studies for the purpose of product labeling are encouraging. © 2016 by American Society of Clinical Oncology.
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75 FR 65362 - Oncologic Drugs Advisory Committee; Notice of Meeting
2010-10-22
... Hampshire Ave., Silver Spring, MD 20993-0002. Information regarding special accommodations due to a... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver...) Soft Gelatin Capsules, [[Page 65363
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Directory of Open Access Journals (Sweden)
Marília Berlofa Visacri
2014-04-01
Full Text Available The high toxicity and narrow therapeutic window of antineoplastic agents makes pharmacovigilance studies essential in oncology. The objectives of the current study were to analyze the pattern of spontaneous notifications of adverse drug reactions (ADRs in oncology patients and to analyze the incidence of ADRs reported by outpatients on antineoplastic treatment in a tertiary care teaching hospital. To compose the pattern of ADR, the notification forms of reactions in oncology patients in 2010 were reviewed, and the reactions were classified based on the drug involved, mechanism, causality, and severity. To evaluate the incidence of reactions, a questionnaire at the time of chemotherapy was included, and the severity was classified based on the Common Terminology Criteria. The profiles of the 10 responses reported to the Pharmacovigilance Sector were type B, severe, possible, and they were primarily related to platinum compounds and taxanes. When the incidence of reactions was analyzed, it was observed that nausea, alopecia, fatigue, diarrhea, and taste disturbance were the most frequently reported reactions by oncology patients, and the grade 3 and 4 reactions were not reported. Based on this analysis, it is proposed that health professionals should be trained regarding notifications and clinical pharmacists should increasingly be brought on board to reduce under-reporting of ADRs.
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Rivera, F; Andres, R; Felip, E; Garcia-Campelo, R; Lianes, P; Llombart, A; Piera, J M; Puente, J; Rodriguez, C A; Vera, R; Virizuela, J A; Martin, M; Garrido, P
2017-04-01
The SEOM Future Plan is aimed at identifying the main challenges, trends and needs of the medical oncology speciality over the next years, including potential oncologist workforce shortages, and proposing recommendations to overcome them. The estimations of the required medical oncologists workforce are based on an updated Medical Oncologist Register in Spain, Medical Oncology Departments activity data, dedication times and projected cancer incidence. Challenges, needs and future recommendations were drawn from an opinion survey and an advisory board. A shortage of 211 FTE medical oncologist specialists has been established. To maintain an optimal ratio of 158 new cases/FTE, medical oncology workforce should reach 1881 FTE by 2035. Main recommendations to face the growing demand and complexity of oncology services include a yearly growth of 2.5% of medical oncologist's workforce until 2035, and development and application of more accurate quality indicators for cancer care and health outcomes measure.
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2012-03-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2002-D-0094; (formerly Docket No. 02D-0049)] Guidance for the Public, Food and Drug Administration (FDA) Advisory... Food and Drug Administration (FDA) is announcing the availability of a guidance for the public, FDA...
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Drug-diagnostics co-development in oncology
Directory of Open Access Journals (Sweden)
Richard eSimon
2013-12-01
Full Text Available Developments in genomics are providing a biological basis for the heterogeneity of clinical course and response to treatment that have long been apparent to clinicians The ability to molecularly characterize of human diseases presents new opportunities to develop more effective treatments and new challenges for the design and analysis of clinical trials.In oncology, treatment of broad populations with regimens that benefit a minority of patients is less economically sustainable with expensive molecularly targeted therapeutics. The established molecular heterogeneity of human diseases requires the development of new paradigms for the design and analysis of randomized clinical trials as a reliable basis for predictive medicine. We review prospective designs for the development of new therapeutics and predictive biomarkers to inform their use. We cover designs for a wide range of settings. At one extreme is the development of a new drug with a single candidate biomarker and strong biological evidence that marker negative patients are unlikely to benefit from the new drug. At the other extreme are phase III clinical trials involving both genome-wide discovery of a predictive classifier and internal validation of that classifier. We have outlined a prediction based approach to the analysis of randomized clinical trials that both preserves the type I error and provides a reliable internally validated basis for predicting which patients are most likely or unlikely to benefit from a new regimen.
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Agur, Zvia; Elishmereni, Moran; Kheifetz, Yuri
2014-01-01
Despite its great promise, personalized oncology still faces many hurdles, and it is increasingly clear that targeted drugs and molecular biomarkers alone yield only modest clinical benefit. One reason is the complex relationships between biomarkers and the patient's response to drugs, obscuring the true weight of the biomarkers in the overall patient's response. This complexity can be disentangled by computational models that integrate the effects of personal biomarkers into a simulator of drug-patient dynamic interactions, for predicting the clinical outcomes. Several computational tools have been developed for personalized oncology, notably evidence-based tools for simulating pharmacokinetics, Bayesian-estimated tools for predicting survival, etc. We describe representative statistical and mathematical tools, and discuss their merits, shortcomings and preliminary clinical validation attesting to their potential. Yet, the individualization power of mathematical models alone, or statistical models alone, is limited. More accurate and versatile personalization tools can be constructed by a new application of the statistical/mathematical nonlinear mixed effects modeling (NLMEM) approach, which until recently has been used only in drug development. Using these advanced tools, clinical data from patient populations can be integrated with mechanistic models of disease and physiology, for generating personal mathematical models. Upon a more substantial validation in the clinic, this approach will hopefully be applied in personalized clinical trials, P-trials, hence aiding the establishment of personalized medicine within the main stream of clinical oncology. © 2014 Wiley Periodicals, Inc.
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Timeline of Authorization and Reimbursement for Oncology Drugs in Italy in the Last 3 Years
Directory of Open Access Journals (Sweden)
Mariangela Prada
Full Text Available Introduction The main purpose of this analysis was to quantify the time elapsed between the validation date of European Medicines Agency (EMA centralized procedure and the first purchase of a product by at least 1 Italian health care structure, evaluating different variables that affect the process, the number of products approved by the Committee for Medicinal Products for Human Use (CHMP that are available on the Italian market (July 2016, and the impact of the Cnn class for oncology drugs in Italy. Methods A panel of oncology products has been defined, which considered drugs approved by the EMA between January 2013 and December 2015, and authorized for the treatment of oncology diseases, excluding generics. Data were obtained via the EMA website by the Agenzia Italiana del Farmaco (AIFA; the Italian Medicine Agency meeting reports, by official administrative acts of marketing authorization, and the date of the first purchase (first day of the first handling month. Results The mean time of EMA evaluation for the considered panel of medicines was about 441 days (standard deviation (SD 108; range 266-770; the average approval time for AIFA was about 248 days (SD 131; range 85-688. Interestingly, the mean AIFA evaluation time decreased significantly from 264 days for products submitted to AIFA assessment in 2013-2014 to 219 days for products evaluated in 2015-2016. Focusing on the regional access, both the timing and the number of drugs available for patients were widely different from region to region. Discussion A reduction in the approval time in the last 2 years has been observed in Italy. However, several variables influence the efficiency of the process and need to be addressed to make the access to drugs timely and efficient.
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Gulten, Tuna; Evke, Elif; Ercan, Ilker; Evrensel, Turkkan; Kurt, Ender; Manavoglu, Osman
2011-01-01
In this study we aimed to investigate the genotoxic effects of antineoplastic agents in occupationally exposed oncology nurses. Genotoxic effects mean the disruptive effects in the integrity of DNA and they are associated with cancer development. Biomonitoring of health care workers handling antineoplastic agents is helpful for the evaluation of exposure to cytostatics. The study included an exposed and two control groups. The exposed group (n=9) was comprised of oncology nurses. The first (n=9) and second (n=10) control groups were comprised of subjects who did not come into contact with antineoplastic drugs working respectively in the same department with oncology nurses and in different departments. Genotoxicity evaluation was performed using SCE analysis. After applying culture, harvest and chromosome staining procedures, a total of 25 metaphases were analyzed per person. Kruskal Wallis test was used to perform statistical analysis. A statistically significant difference of sister chromatid exchange frequencies was not observed between the exposed and control groups. Lack of genotoxicity in medical oncology nurses might be due to good working conditions with high standards of technical equipment and improved personal protection.
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75 FR 80059 - Advisory Committees; Tentative Schedule of Meetings for 2011
2010-12-21
.... Drugs Advisory Committee. Advisory Committee for Pharmaceutical March 2. Science and Clinical.... Science Board to the Food and Drug February 25, May 20, August 19, Administration. November 10. CENTER FOR... CENTER FOR TOXICOLOGICAL RESEARCH Science Advisory Board November 9-10. Dated: December 16, 2010. Jill...
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Directory of Open Access Journals (Sweden)
Hoeksema KA
2011-09-01
Full Text Available Kimberley A Hoeksema1, Aarthi Jayanthan1, Todd Cooper2, Lia Gore3, Tanya Trippett4, Jessica Boklan6, Robert J Arceci5, Aru Narendran11Division of Pediatric Oncology, Alberta Children's Hospital, Calgary, AB, Canada; 2Aflac Cancer Center and Blood Disorders Service, Children's Healthcare of Atlanta, Emory University, Atlanta, GA, USA; 3Center for Cancer and Blood Disorders, Children's Hospital, University of Colorado Denver, Aurora, CO, USA; 4Memorial Sloan-Kettering Cancer Center, New York, NY, USA; 5Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA; 6Center for Cancer and Blood Disorders, Phoenix Children's Hospital, Phoenix, AZ, USAAbstract: Despite significant progress made in the overall cure rate, the prognosis for relapsed and refractory malignancies in children remains extremely poor. Hence, there is an urgent need for studies that enable the timely selection of appropriate agents for Phase I clinical studies. The Pediatric Oncology Experimental Therapeutics Investigators' Consortium (POETIC is systematically evaluating libraries of known and novel compounds for activity against subsets of high-risk pediatric malignancies with defined molecular aberrations for future clinical development. In this report, we describe the in-vitro activity of a diverse panel of approved oncology drugs against MLL-rearranged pediatric leukemia cell lines. Agents in the Approved Oncology Drug Set II (National Cancer Institute/National Institutes of Health Developmental Therapeutics Program were evaluated by in-vitro cytotoxicity assays in pediatric acute lymphoblastic leukemia and acute myeloid leukemia cell lines with MLL gene rearrangements. Validation studies were carried out with patient leukemia cells in culture. Comparative analysis for toxicity against nonmalignant cells was evaluated in normal bone marrow stromal cells and normal human lymphocytes. Results from this study show that 42 of the 89 agents tested have
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76 FR 78931 - Advisory Committees; Tentative Schedule of Meetings for 2012
2011-12-20
..., April 30, May 1, August 16-17, November 1-2. Science Board to FDA January 6, May 2, October 3. CENTER... Date(s), if needed, to be Drugs Advisory Committee. determined. Advisory Committee for Pharmaceutical March 14. Science and Clinical Pharmacology. Psychopharmacologic Drugs Advisory Date(s), if needed, to...
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Menendez, Javier A
2015-01-01
The current global portfolio of oncology drugs is unlikely to produce durable disease remission for millions of cancer patients worldwide. This is due, in part, to the existence of so-called cancer stem cells (CSCs), a particularly aggressive type of malignant cell that is capable of indefinite self-replication, is refractory to conventional treatments, and is skilled at spreading and colonizing distant organs. To date, no drugs from big-league Pharma companies are capable of killing CSCs. Why? Quite simply, a classic drug development approach based on mutated genes and pathological protein products cannot efficiently target the plastic, epigenetic proclivity of cancer tissues to generate CSCs. Recent studies have proposed that certain elite metabolites (oncometabolites) and other common metabolites can significantly influence the establishment and maintenance of epigenetic signatures of stemness and cancer. Consequently, cellular metabolism and the core epigenetic codes, DNA methylation and histone modification, can be better viewed as an integrated metaboloepigenetic dimension of CSCs, which we have recently termed cancer metabostemness. By targeting weaknesses in the bridge connecting metabolism and epigenetics, a new generation of metabostemnessspecific drugs can be generated for potent and long-lasting elimination of life-threatening CSCs. Here I evaluate the market potential of re-modeling the oncology drug pipeline by discovering and developing new metabolic approaches able to target the apparently undruggable epigenetic programs that dynamically regulate the plasticity of non-CSC and CSC cellular states.
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New Drug Reimbursement and Pricing Policy in Taiwan.
Chen, Gau-Tzu; Chang, Shu-Chen; Chang, Chee-Jen
2018-05-01
Taiwan has implemented a national health insurance system for more than 20 years now. The benefits of pharmaceutical products and new drug reimbursement scheme are determined by the Expert Advisory Meeting and the Pharmaceutical Benefit and Reimbursement Scheme (PBRS) Joint Committee in Taiwan. To depict the pharmaceutical benefits and reimbursement scheme for new drugs and the role of health technology assessment (HTA) in drug policy in Taiwan. All data were collected from the Expert Advisory Meeting and the PBRS meeting minutes; new drug applications with HTA reports were derived from the National Health Insurance Administration Web site. Descriptive statistics were used to analyze the timeline of a new drug from application submission to reimbursement effective, the distribution of approved price, and the approval rate for a new drug with/without local pharmacoeconomic study. After the second-generation national health insurance system, the timeline for a new drug from submission to reimbursement effective averages at 436 days, and that for an oncology drug reaches an average of 742 days. New drug approval rate is 67% and the effective rate (through the approval of the PBRS Joint Committee and the acceptance of the manufacturer) is 53%. The final approved price is 53.6% of the international median price and 70% of the proposed price by the manufacturer. Out of 95 HTA reports released during the period January 2011 to February 2017, 28 applications (30%) conducted an HTA with a local pharmacoeconomic study, and all (100%) received reimbursement approval. For the remaining 67 applications (70%) for which HTA was conducted without a local pharmacoeconomic analysis, 54 cases (81%) were reimbursed. New drug applications with local pharmacoeconomic studies are more likely to get reimbursement. Copyright © 2018. Published by Elsevier Inc.
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Frame, James N.; Jacobson, Joseph O.; Vogel, Wendy H.; Griffith, Niesha; Wariabharaj, Darshan; Garg, Rekha; Zon, Robin; Stephens, Cyntha L.; Bialecki, Alison M.; Bruinooge, Suanna S.; Allen, Steven L.
2013-01-01
To address oncology community stakeholder concerns regarding implementation of the Risk Evaluation and Mitigation Strategies (REMS) program, ASCO sponsored a workshop to gather REMS experiences from representatives of professional societies, patient organizations, pharmaceutical companies, and the US Food and Drug Administration (FDA). Stakeholder presentations and topical panel discussions addressed REMS program development, implementation processes, and practice experiences, as well as oncology drug safety processes. A draft REMS decision tool prepared by the ASCO REMS Steering Committee was presented for group discussion with facilitated, goal-oriented feedback. The workshop identified several unintended consequences resulting from current oncology REMS: (1) the release of personal health information to drug sponsors as a condition for gaining access to a needed drug; (2) risk information that is not tailored—and therefore not accessible—to all literacy levels; (3) exclusive focus on drug risk, thereby affecting patient-provider treatment discussion; (4) REMS elements that do not consider existing, widely practiced oncology safety standards, professional training, and experience; and (5) administrative burdens that divert the health care team from direct patient care activities and, in some cases, could limit patient access to important therapies. Increased provider and professional society participation should form the basis of ongoing and future REMS standardization discussions with the FDA to work toward overall improvement of risk communication. PMID:23814522
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Directory of Open Access Journals (Sweden)
2010-01-01
Full Text Available Cancer patients undergoing chemotherapy are particularly susceptible to drug-drug interactions (DDIs. Practitioners should keep themselves updated with the most current DDI information, particularly involving new anticancer drugs (ACDs. Databases can be useful to obtain up-to-date DDI information in a timely and efficient manner. Our objective was to investigate the DDI information sources of pharmacy practitioners in Asia and their views on the usefulness of an oncology-specific database for ACD interactions. A qualitative, cross-sectional survey was done to collect information on the respondents' practice characteristics, sources of DDI information and parameters useful in an ACD interaction database. Response rate was 49%. Electronic databases (70%, drug interaction textbooks (69% and drug compendia (64% were most commonly used. Majority (93% indicated that a database catering towards ACD interactions was useful. Essential parameters that should be included in the database were the mechanism and severity of the detected interaction, and the presence of a management plan (98% each. This study has improved our understanding on the usefulness of various DDI information sources for ACD interactions among pharmacy practitioners in Asia. An oncology-specific DDI database targeting ACD interactions is definitely attractive for clinical practice.
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76 FR 52334 - Arthritis Advisory Committee; Notice of Postponement of Meeting
2011-08-22
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Arthritis Advisory Committee; Notice of Postponement of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is postponing the Arthritis Advisory...
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75 FR 55805 - Arthritis Advisory Committee; Notice of Meeting
2010-09-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee...
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76 FR 42715 - Arthritis Advisory Committee; Notice of Meeting
2011-07-19
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee...
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77 FR 13611 - Arthritis Advisory Committee; Notice of Meeting
2012-03-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee...
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77 FR 1697 - Arthritis Advisory Committee; Notice of Meeting
2012-01-11
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee...
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78 FR 33423 - Arthritis Advisory Committee; Notice of Meeting
2013-06-04
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee...
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77 FR 70450 - Risk Communication Advisory Committee; Notice of Meeting
2012-11-26
...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... 1. Contact Person: Lee L. Zwanziger, Risk Communication Staff, Food and Drug Administration, 10903...
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77 FR 62242 - Risk Communication Advisory Committee; Notice of Meeting
2012-10-12
...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... Person: Lee L. Zwanziger, Risk Communication Staff, Office of Planning, Food and Drug Administration...
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Individualization of anticancer therapy; molecular targets of novel drugs in oncology
Directory of Open Access Journals (Sweden)
Katarzyna Regulska
2012-11-01
Full Text Available Deregulation of cellular signal transduction, caused by gene mutations, has been recognized as a basic factor of cancer initiation, promotion and progression. Thus, the ability to control the activity of overstimulated signal molecules by the use of appropriate inhibitors became the idea of targeted cancer therapy, which has provided an effective tool to normalize the molecular disorders in malignant cells and to treat certain types of cancer. The molecularly targeted drugs are divided into two major pharmaceutical classes: monoclonal antibodies and small-molecule kinase inhibitors. This review presents a summary of their characteristics, analyzing their chemical structures, specified molecular targets, mechanisms of action and indications for use. Also the molecules subjected to preclinical trials or phase I, II and III clinical trials evaluating their efficiency and safety are presented. Moreover, the article discusses further perspectives for development of targeted therapies focusing on three major directions: systematic searching and discovery of new targets that are oncogenic drivers, improving the pharmacological properties of currently known drugs, and developing strategies to overcome drug resistance. Finally, the role of proper pharmacodiagnostics as a key to rational anticancer therapy has been emphasized since the verification of reliable predictive biomarkers is a basis of individualized medicine in oncology.
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Precision oncology: origins, optimism, and potential.
Prasad, Vinay; Fojo, Tito; Brada, Michael
2016-02-01
Imatinib, the first and arguably the best targeted therapy, became the springboard for developing drugs aimed at molecular targets deemed crucial to tumours. As this development unfolded, a revolution in the speed and cost of genetic sequencing occurred. The result--an armamentarium of drugs and an array of molecular targets--set the stage for precision oncology, a hypothesis that cancer treatment could be markedly improved if therapies were guided by a tumour's genomic alterations. Drawing lessons from the biological basis of cancer and recent empirical investigations, we take a more measured view of precision oncology's promise. Ultimately, the promise is not our concern, but the threshold at which we declare success. We review reports of precision oncology alongside those of precision diagnostics and novel radiotherapy approaches. Although confirmatory evidence is scarce, these interventions have been widely endorsed. We conclude that the current path will probably not be successful or, at a minimum, will have to undergo substantive adjustments before it can be successful. For the sake of patients with cancer, we hope one form of precision oncology will deliver on its promise. However, until confirmatory studies are completed, precision oncology remains unproven, and as such, a hypothesis in need of rigorous testing. Copyright © 2016 Elsevier Ltd. All rights reserved.
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75 FR 4576 - Veterinary Medicine Advisory Committee; Notice of Meeting
2010-01-28
...] Veterinary Medicine Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). The meeting will be open to the public. Name of Committee: Veterinary Medicine Advisory... Sindelar, Center for Veterinary Medicine (HFV-3), Food and Drug Administration, 7519 Standish Pl...
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Transparency in Canadian public drug advisory committees.
Rosenberg-Yunger, Zahava R S; Bayoumi, Ahmed M
2014-11-01
Transparency in health care resource allocation decisions is a criterion of a fair process. We used qualitative methods to explore transparency across 11 Canadian drug advisory committees. We developed seven criteria to assess transparency (disclosure of members' names, disclosure of membership selection criteria, disclosure of conflict of interest guidelines and members' conflicts, public posting of decisions not to fund drugs, public posting of rationales for decisions, stakeholder input, and presence of an appeals mechanism) and two sub-criteria for when rationales were posted (direct website link and readability). We interviewed a purposeful sample of key informants who were conversant in English and a current or past member of either a committee or a stakeholder group. We analyzed data using a thematic approach. Interviewing continued until saturation was reached. We examined documents from 10 committees and conducted 27 interviews. The median number of criteria addressed by committees was 2 (range 0-6). Major interview themes included addressing: (1) accessibility issues, including stakeholders' degree of access to the decision making process and appeal mechanisms; (2) communication issues, including improving internal and external communication and public access to information; and (3) confidentiality issues, including the use of proprietary evidence. Most committees have some mechanisms to address transparency but none had a fully transparent process. The most important ways to improve transparency include creating formal appeal mechanisms, improving communication, and establishing consistent rules about the use of, and public access to, proprietary evidence. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.
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76 FR 44017 - Risk Communication Advisory Committee; Notice of Meeting
2011-07-22
...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... and former members of the Risk Communication Advisory Committee. FDA intends to make background...
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Utilization of the Bridging Strategy for the Development of New Drugs in Oncology to Avoid Drug Lag.
Kogure, Seiji; Koyama, Nobuyuki; Hidaka, Shinji
2017-11-01
Global trial (GT) strategy and bridging (BG) strategy are currently the main clinical development strategies of oncology drugs in Japan, but the relationship between development style and drug lag and how the bridging strategy has contributed to the solution of drug lag have not been clear. We investigated the potential factors that influenced submission lag (SL), and also compared the differences in SL among early-initiation BG strategy, late-initiation BG strategy, and GT strategy. A stepwise linear regression analysis identified the potential factors that shorten SL: development start lag and development style. Comparison of the differences in SL among the strategies also indicated that the SL in the GT strategy and that in the early-initiation BG strategy were significantly shorter than that in the late-initiation BG strategy. The findings in our study suggest that the late-initiation BG strategy may not contribute to shortening drug lag. Because the number of late-initiation BG studies has not decreased, we propose first that pharmaceutical companies should initiate clinical development as early as possible in Japan so that they can choose the GT strategy as a first option at the next step, and second when they cannot choose the GT strategy after investigating differences in exposure between Japanese and non-Japanese in a phase 1 study, they should select the early BG strategy to avoid future drug lag. It is also important for the regulatory authorities to provide reasonable guidance to have a positive impact on strategic decisions, even for foreign-capital companies. © 2017, The American College of Clinical Pharmacology.
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[Quality assurance in head and neck medical oncology].
Digue, Laurence; Pedeboscq, Stéphane
2014-05-01
In medical oncology, how can we be sure that the right drug is being administered to the right patient at the right time? The implementation of quality assurance criteria is important in medical oncology, in order to ensure that the patient receives the best treatment safely. There is very little literature about quality assurance in medical oncology, as opposed to radiotherapy or cancer surgery. Quality assurance must cover the entire patient care process, from the diagnosis, to the therapeutic decision and drug distribution, including its selection, its preparation and its delivery to the patient (administration and dosage), and finally the potential side effects and their management. The dose-intensity respect is crucial, and its reduction can negatively affect overall survival rates, as shown in breast and testis cancers for example. In head and neck medical oncology, it is essential to respect the few well-standardized recommendations and the dose-intensity, in a population with numerous comorbidities. We will first review quality assurance criteria for the general medical oncology organization and then focus on head and neck medical oncology. We will then describe administration specificities of head and neck treatments (chemoradiation, radiation plus cetuximab, postoperative chemoradiation, induction and palliative chemotherapy) as well as their follow-up. Lastly, we will offer some recommendations to improve quality assurance in head and neck medical oncology.
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75 FR 65641 - Risk Communication Advisory Committee; Amendment of Notice
2010-10-26
...] Risk Communication Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS... meeting of the Risk Communication Advisory Committee. This meeting was announced in the Federal Register... Communication Advisory Committee would be held on November 8 and 9, 2010. On page 57280, in the first column...
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21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Utilization of an advisory committee on the initiative of FDA. 14.171 Section 14.171 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... technical advisory committee for human prescription drugs. The Commissioner's determinations on the agenda...
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76 FR 5380 - Advisory Committees; Filing of Closed Meeting Reports
2011-01-31
...] Advisory Committees; Filing of Closed Meeting Reports AGENCY: Food and Drug Administration, HHS. ACTION... Advisory Committee Act, the Agency has filed with the Library of Congress the annual reports of those FDA...), FDA has filed with the Library of Congress the annual reports for the following FDA advisory...
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78 FR 12068 - Device Good Manufacturing Practice Advisory Committee; Notice of Meeting
2013-02-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Device Good Manufacturing Practice Advisory Committee; Notice of Meeting AGENCY: Food and Drug... Committee: Device Good Manufacturing Practice Advisory Committee. General Function of the Committee: To...
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Nanomedicine in veterinary oncology.
Lin, Tzu-Yin; Rodriguez, Carlos O; Li, Yuanpei
2015-08-01
Nanomedicine is an interdisciplinary field that combines medicine, engineering, chemistry, biology and material sciences to improve disease management and can be especially valuable in oncology. Nanoparticle-based agents that possess functions such as tumor targeting, imaging and therapy are currently under intensive investigation. This review introduces the basic concept of nanomedicine and the classification of nanoparticles. Because of their favorable pharmacokinetics, tumor targeting properties, and resulting superior efficacy and toxicity profiles, nanoparticle-based agents can overcome several limitations associated with conventional diagnostic and therapeutic protocols in veterinary oncology. The two most important tumor targeting mechanisms (passive and active tumor targeting) and their dominating factors (i.e. shape, charge, size and nanoparticle surface display) are discussed. The review summarizes published clinical and preclinical studies that utilize different nanoformulations in veterinary oncology, as well as the application of nanoparticles for cancer diagnosis and imaging. The toxicology of various nanoformulations is also considered. Given the benefits of nanoformulations demonstrated in human medicine, nanoformulated drugs are likely to gain more traction in veterinary oncology. Published by Elsevier Ltd.
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Factors influencing oncology nurses' use of hazardous drug safe-handling precautions.
Polovich, Martha; Clark, Patricia C
2012-05-01
To examine relationships among factors affecting nurses' use of hazardous drug (HD) safe-handling precautions, identify factors that promote or interfere with HD precaution use, and determine managers' perspectives on the use of HD safe-handling precautions. Cross-sectional, mixed methods; mailed survey to nurses who handle chemotherapy and telephone interviews with managers. Mailed invitation to oncology centers across the United States. 165 nurses who reported handling chemotherapy and 20 managers of nurses handling chemotherapy. Instruments measured the use of HD precautions and individual and organizational factors believed to influence precaution use. Data analysis included descriptive statistics and hierarchical regression. Manager interview data were analyzed using content analysis. Chemotherapy exposure knowledge, self-efficacy, perceived barriers, perceived risk, interpersonal influences, and workplace safety climate. Nurses were well educated, experienced, and certified in oncology nursing. The majority worked in outpatient settings and administered chemotherapy to an average of 6.8 patients per day. Exposure knowledge, self-efficacy for using personal protective equipment, and perceived risk of harm from HD exposure were high; total precaution use was low. Nurse characteristics did not predict HD precaution use. Fewer barriers, better workplace safety climate, and fewer patients per day were independent predictors of higher HD precaution use. HD handling policies were present, but many did not reflect current recommendations. Few managers formally monitored nurses' HD precaution use. Circumstances in the workplace interfere with nurses' use of HD precautions. Interventions should include fostering a positive workplace safety climate, reducing barriers, and providing appropriate nurse-patient ratios.
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2011-07-29
... syndrome (AIDS), HIV-related illnesses, and other viral, fungal, and mycobacterial infections. F. Arthritis... the treatment of a broad spectrum of human symptoms and diseases. N. Oncologic Drugs Advisory...
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Pharmacovigilance training for specialist oncology nurses-a two way evaluation
Schutte, T.; Van Eekeren, R.; Richir, M.; Van Staveren, J.; Van Puijenbroek, E.P.; Tichelaar, J.; Van Agtmael, M.A.
2017-01-01
Background: In a new prescribing qualifcation course for specialist oncology nurses, we thought it important to emphasize pharma-covigilance and adverse drug reaction (ADR)-reporting. To this end, our aim was to develop and evaluate an ADR reporting assignment for specialist oncology nurses.
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75 FR 66381 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
2010-10-28
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide...
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76 FR 49774 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
2011-08-11
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide...
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76 FR 64951 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
2011-10-19
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide...
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78 FR 15726 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
2013-03-12
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of...
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International Nuclear Information System (INIS)
Inubushi, Masayuki
2014-01-01
At the beginning of this article, likening medical images to 'Where is Waldo?' I indicate the concept of diagnostic process of PET/CT imaging, so that medical physics specialists could understand the role of each imaging modality and infer our distress for image diagnosis. Then, I state the present situation of PET imaging and the basics (e.g. health insurance coverage, clinical significance, principle, protocol, and pitfall) of oncology FDG-PET imaging which accounts for more than 99% of all clinical PET examinations in Japan. Finally, I would like to give a wishful prospect of oncology PET that will expand to be more cancer-specific in order to assess therapeutic effects of emerging molecular targeted drugs targeting the 'hallmarks of cancer'. (author)
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78 FR 32403 - Arthritis Advisory Committee; Notice of Meeting
2013-05-30
...] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee..., the committee will discuss the Assessment of SpondyloArthritis international Society classification...
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International Nuclear Information System (INIS)
Connor, Michael J.; Tringale, Kathryn; Moiseenko, Vitali; Marshall, Deborah C.; Moore, Kevin; Cervino, Laura; Atwood, Todd; Brown, Derek; Mundt, Arno J.; Pawlicki, Todd; Recht, Abram; Hattangadi-Gluth, Jona A.
2017-01-01
Purpose: To analyze all recalls involving radiation oncology devices (RODs) from the US Food and Drug Administration (FDA)'s recall database, comparing these with non–radiation oncology device recalls to identify discipline-specific trends that may inform improvements in device safety. Methods and Materials: Recall data on RODs from 2002 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems). Outcomes included determined cause of recall, recall class (severity), quantity in commerce, time until recall termination (date FDA determines recall is complete), and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by Pearson χ"2 test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions. Results: There were 502 ROD recalls and 9534 other class II device recalls during 2002 to 2015. Most recalls were for external beam devices (66.7%) and planning systems (22.9%), and recall events peaked in 2011. Radiation oncology devices differed significantly from other devices in all recall outcomes (P≤.04). Recall cause was commonly software related (49% vs 10% for other devices). Recall severity was more often moderate among RODs (97.6% vs 87.2%) instead of severe (0.2% vs 4.4%; P<.001). Time from 510(k) market approval to recall was shorter among RODs (P<.001) and progressively shortened over time. Radiation oncology devices had fewer recalled devices in commerce than other devices (P<.001). Conclusions: Compared with other class II devices, RODs experience recalls sooner after market approval and are trending sooner still. Most of these recalls were moderate in severity, and software issues are prevalent. Comprehensive analysis of recall data can identify areas for device improvement, such as better system design among RODs.
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Energy Technology Data Exchange (ETDEWEB)
Connor, Michael J. [Department of Radiation Medicine and Applied Sciences, University of California, San Diego, La Jolla, California (United States); University of California Irvine School of Medicine, Irvine, California (United States); Tringale, Kathryn; Moiseenko, Vitali; Marshall, Deborah C.; Moore, Kevin; Cervino, Laura; Atwood, Todd; Brown, Derek; Mundt, Arno J.; Pawlicki, Todd [Department of Radiation Medicine and Applied Sciences, University of California, San Diego, La Jolla, California (United States); Recht, Abram [Department of Radiation Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (United States); Hattangadi-Gluth, Jona A., E-mail: jhattangadi@ucsd.edu [Department of Radiation Medicine and Applied Sciences, University of California, San Diego, La Jolla, California (United States)
2017-06-01
Purpose: To analyze all recalls involving radiation oncology devices (RODs) from the US Food and Drug Administration (FDA)'s recall database, comparing these with non–radiation oncology device recalls to identify discipline-specific trends that may inform improvements in device safety. Methods and Materials: Recall data on RODs from 2002 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems). Outcomes included determined cause of recall, recall class (severity), quantity in commerce, time until recall termination (date FDA determines recall is complete), and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by Pearson χ{sup 2} test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions. Results: There were 502 ROD recalls and 9534 other class II device recalls during 2002 to 2015. Most recalls were for external beam devices (66.7%) and planning systems (22.9%), and recall events peaked in 2011. Radiation oncology devices differed significantly from other devices in all recall outcomes (P≤.04). Recall cause was commonly software related (49% vs 10% for other devices). Recall severity was more often moderate among RODs (97.6% vs 87.2%) instead of severe (0.2% vs 4.4%; P<.001). Time from 510(k) market approval to recall was shorter among RODs (P<.001) and progressively shortened over time. Radiation oncology devices had fewer recalled devices in commerce than other devices (P<.001). Conclusions: Compared with other class II devices, RODs experience recalls sooner after market approval and are trending sooner still. Most of these recalls were moderate in severity, and software issues are prevalent. Comprehensive analysis of recall data can identify areas for device improvement, such as better system design among RODs.
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Directory of Open Access Journals (Sweden)
Mansutti Mauro
2008-04-01
Full Text Available Abstract Background Cost-containment strategies are required to face the challenge of rising drug expenditures in Oncology. Drug wastage leads to economic loss, but little is known about the size of the problem in this field. Methods Starting January 2005 we introduced a day-to-day monitoring of drug wastage and an accurate assessment of its costs. An internal protocol for waste minimisation was developed, consisting of four corrective measures: 1. A rational, per pathology distribution of chemotherapy sessions over the week. 2. The use of multi-dose vials. 3. A reasonable rounding of drug dosages. 4. The selection of the most convenient vial size, depending on drug unit pricing. Results Baseline analysis focused on 29 drugs over one year. Considering their unit price and waste amount, a major impact on expense was found to be attributable to six drugs: cetuximab, docetaxel, gemcitabine, oxaliplatin, pemetrexed and trastuzumab. The economic loss due to their waste equaled 4.8% of the annual drug expenditure. After the study protocol was started, the expense due to unused drugs showed a meaningful 45% reduction throughout 2006. Conclusion Our experience confirms the economic relevance of waste minimisation and may represent a feasible model in addressing this issue. A centralised unit of drug processing, the availability of a computerised physician order entry system and an active involvement of the staff play a key role in allowing waste reduction and a consequent, substantial cost-saving.
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75 FR 5335 - Risk Communication Advisory Committee; Notice of Meeting
2010-02-02
...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... previously issued communications, emphasizing communications challenges. Examples, selected for illustrative...
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77 FR 14529 - Arthritis Advisory Committee; Notice of Meeting
2012-03-12
...] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee... the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had...
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Connor, Michael J; Tringale, Kathryn; Moiseenko, Vitali; Marshall, Deborah C; Moore, Kevin; Cervino, Laura; Atwood, Todd; Brown, Derek; Mundt, Arno J; Pawlicki, Todd; Recht, Abram; Hattangadi-Gluth, Jona A
2017-06-01
To analyze all recalls involving radiation oncology devices (RODs) from the US Food and Drug Administration (FDA)'s recall database, comparing these with non-radiation oncology device recalls to identify discipline-specific trends that may inform improvements in device safety. Recall data on RODs from 2002 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems). Outcomes included determined cause of recall, recall class (severity), quantity in commerce, time until recall termination (date FDA determines recall is complete), and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by Pearson χ 2 test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions. There were 502 ROD recalls and 9534 other class II device recalls during 2002 to 2015. Most recalls were for external beam devices (66.7%) and planning systems (22.9%), and recall events peaked in 2011. Radiation oncology devices differed significantly from other devices in all recall outcomes (P≤.04). Recall cause was commonly software related (49% vs 10% for other devices). Recall severity was more often moderate among RODs (97.6% vs 87.2%) instead of severe (0.2% vs 4.4%; Panalysis of recall data can identify areas for device improvement, such as better system design among RODs. Copyright © 2017 Elsevier Inc. All rights reserved.
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76 FR 58519 - Risk Communication Advisory Committee; Notice of Meeting
2011-09-21
...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... discuss implications, for strategic communication, of recent theoretical developments on information use...
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76 FR 29767 - Arthritis Advisory Committee; Notice of Meeting
2011-05-23
...] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee... indication: ``ILARIS is indicated for the treatment of gouty arthritis attacks. ILARIS has also been shown to...
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75 FR 57279 - Risk Communication Advisory Committee; Notice of Meeting
2010-09-20
...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... Committee will hear and discuss developments in FDA's ongoing communications programs, such as FDA's...
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Engineering and physical sciences in oncology: challenges and opportunities.
Mitchell, Michael J; Jain, Rakesh K; Langer, Robert
2017-11-01
The principles of engineering and physics have been applied to oncology for nearly 50 years. Engineers and physical scientists have made contributions to all aspects of cancer biology, from quantitative understanding of tumour growth and progression to improved detection and treatment of cancer. Many early efforts focused on experimental and computational modelling of drug distribution, cell cycle kinetics and tumour growth dynamics. In the past decade, we have witnessed exponential growth at the interface of engineering, physics and oncology that has been fuelled by advances in fields including materials science, microfabrication, nanomedicine, microfluidics, imaging, and catalysed by new programmes at the National Institutes of Health (NIH), including the National Institute of Biomedical Imaging and Bioengineering (NIBIB), Physical Sciences in Oncology, and the National Cancer Institute (NCI) Alliance for Nanotechnology. Here, we review the advances made at the interface of engineering and physical sciences and oncology in four important areas: the physical microenvironment of the tumour and technological advances in drug delivery; cellular and molecular imaging; and microfluidics and microfabrication. We discussthe research advances, opportunities and challenges for integrating engineering and physical sciences with oncology to develop new methods to study, detect and treat cancer, and we also describe the future outlook for these emerging areas.
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International Nuclear Information System (INIS)
Shaikenov, T.; Karabalin, B.; Rakhimov, K.; Adekenov, S.
1996-01-01
Background: One of the heaviest effects of radiation exposure and its pollutants to the environment is a growth of oncologic diseases as a sequence of breakage of genetic body substance and transmission of Genetic load to the next generation. People of Kazakstan are anxious of the present situation with harmful effect of remaining radiation doses.Purpose of research: the examination of molecular mechanisms of action for a new drug 'Arglabin' was done with the purpose of preventing the malignant tumor occurrence for those people living on the territory of higher risk (in high radiation locations). Research work of the mechanisms of action for 'Arglabin' drug: - examination of the drug effectiveness to enzymes of prenylated proteins; - examination of the drug effectiveness on functioning the oncogene products; - examination of drug metabolism. Research work of the possibility for using 'Arglabin' to prevent oncology diseases includes: - establishment of experimental model of increased risk of oncologic disease on different groups of laboratory animals using the low-dosage radiation sphere; - examination of the drug effectiveness in oncology diseases prevention; - determination of mechanisms and the prevention's results on cancer
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76 FR 16427 - Risk Communication Advisory Committee; Notice of Meeting
2011-03-23
...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... discuss developments in FDA's ongoing communications programs. The discussion will focus on the use of...
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75 FR 20608 - Risk Communication Advisory Committee; Notice of Meeting
2010-04-20
...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... relevant to improving risk communication at FDA, and discuss applications or gaps for strategic planning of...
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77 FR 65693 - Cellular, Tissue and Gene Therapies Advisory Committee; Amendment of Notice
2012-10-30
...] Cellular, Tissue and Gene Therapies Advisory Committee; Amendment of Notice AGENCY: Food and Drug... notice of a meeting of the Cellular, Tissue and Gene Therapies Advisory Committee. This meeting was... announced that a meeting of the Cellular, Tissue and Gene Therapies Advisory Committee would be held on...
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Directory of Open Access Journals (Sweden)
Jorge L. Soriano García
2007-08-01
indirectos. Conclusiones: Constituye el primer reporte de un sistema integrado de prevención de errores en los antineoplásicos en países con recursos limitados y puede, por su sencillez y factibilidad, ser aplicado en cualquiera de estos países.Justification: Medication mistakes in case of chemotherapy or adjuvant treatment used in any stage of drug application process: prescription, transcription, preparation, dispense or administration, are a frequent cause of side effects of antineoplastic drugs. Methods: Main sourses of information were meetings to analyze application of quality guarantee program in Oncology in services and the revision of medical literature published in from 1995 to January 2006, appeared in MEDLINE. Searching strategy was performed under headings “mediction errors” and “chemotherapy”. Additional searches were performed under headings “safety patient”, “antineoplastic drugs”, “preventing medications errors”, and were combined each other. Results: Experience of Oncology Service from “Hermanos Ameijeiras” Clinical Surgical Hospital was exposed as for application of work strategy related to error prevention in administration of drugs in above service from year 2000. To date, some novel features has been applied: forms for chemotherapeutic treatment, standardized suggestions in pre-printed sheets, drugs dilution tables, new organizing nursing systems, and report sheets in case of patient toxicity. Application of above strategy involves antineoplastic chemotherapy, and global survival of patients. It contributes to reduct direct health expenses (decrease in complications and treatment derived from it, real time of staff in different phases of drug use process, and consumption of cytostatic sera and indirect charges. Conclusions: This is the first report from aa integrated system of error prevention in antineoplastic drugs in countries with limites resources, and by its simplicity and feasibility, may be applied in any of these
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21 CFR 14.95 - Compensation of advisory committee members.
2010-04-01
... employees, but are reimbursed by the Food and Drug Administration for travel expenses. (b) Notwithstanding... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Compensation of advisory committee members. 14.95 Section 14.95 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL...
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Mattes, Malcolm D; Swart, Elizabeth; Markwell, Steven M; Wen, Sijin; Vona-Davis, Linda C
2017-09-15
Little is known about how clinical oncology concepts are taught to PhD students or the most effective methods of doing so. In this study, electronic surveys were sent to faculty and students at PhD training programs, assessing their institution's methods of clinical oncology education and their perspective on optimal approaches to clinical oncology education. Only 40.0% of students reported any clinical oncology component to their institution's training, and only 26.5% had a clinician on their graduate advisory committee. Forty-three percent of students believed that they had a good understanding for translating basic science research into clinical practice, and 77.2% of all participants believed dual degree MD/PhD students were superior to PhD students in this regard. Lectures on clinical oncology research topics were the most valuable type of experience for all participants and were also the most common type of experience utilized. Working with a clinician to develop a clinical trial with correlative endpoints was also highly valued, but was only utilized by approximately 10% of programs. Faculty rated the value of nearly all types of clinical oncology exposure significantly lower than did students. Inclusion of the approaches identified in this study is likely to enhance PhD training in oncology-related disciplines. Cancer Res; 77(18); 4741-4. ©2017 AACR . ©2017 American Association for Cancer Research.
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75 FR 52605 - Veterinary Medicine Advisory Committee; Notice of Meeting
2010-08-26
...] Veterinary Medicine Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). The meeting will be open to the public. Name of Committee: Veterinary Medicine Advisory..., Rockville, MD 20852, 301-468-1100. Contact Person: Aleta Sindelar, Center for Veterinary Medicine (HFV-3...
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Bentley, Tanya G K; Cohen, Joshua T; Elkin, Elena B; Huynh, Julie; Mukherjea, Arnab; Neville, Thanh H; Mei, Matthew; Copher, Ronda; Knoth, Russell; Popescu, Ioana; Lee, Jackie; Zambrano, Jenelle M; Broder, Michael S
2017-06-01
Several organizations have developed frameworks to systematically assess the value of new drugs. To evaluate the convergent validity and interrater reliability of 4 value frameworks to understand the extent to which these tools can facilitate value-based treatment decisions in oncology. Eight panelists used the American Society of Clinical Oncology (ASCO), European Society for Medical Oncology (ESMO), Institute for Clinical and Economic Review (ICER), and National Comprehensive Cancer Network (NCCN) frameworks to conduct value assessments of 15 drugs for advanced lung and breast cancers and castration-refractory prostate cancer. Panelists received instructions and published clinical data required to complete the assessments, assigning each drug a numeric or letter score. Kendall's Coefficient of Concordance for Ranks (Kendall's W) was used to measure convergent validity by cancer type among the 4 frameworks. Intraclass correlation coefficients (ICCs) were used to measure interrater reliability for each framework across cancers. Panelists were surveyed on their experiences. Kendall's W across all 4 frameworks for breast, lung, and prostate cancer drugs was 0.560 (P= 0.010), 0.562 (P = 0.010), and 0.920 (P fair to excellent, increasing with clinical benefit subdomain concordance and simplicity of drug trial data. Interrater reliability, highest for ASCO and ESMO, improved with clarity of instructions and specificity of score definitions. Continued use, analyses, and refinements of these frameworks will bring us closer to the ultimate goal of using value-based treatment decisions to improve patient care and outcomes. This work was funded by Eisai Inc. Copher and Knoth are employees of Eisai Inc. Bentley, Lee, Zambrano, and Broder are employees of Partnership for Health Analytic Research, a health services research company paid by Eisai Inc. to conduct this research. For this study, Cohen, Huynh, and Neville report fees from Partnership for Health Analytic Research
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2013-05-08
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Microbiology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...
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76 FR 48871 - Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
2011-08-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Immunology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...
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The birth of the subspecialty of medical oncology and examples of its early scientific foundations.
Band, Pierre R
2010-08-01
"Passion is not accepting defeat."--Emil Frei III. In the early 1950s, an experimental and clinical program characterized by unique cross-fertilization was developed. The clinical importance of experimental animal models in drug screening and in establishing key chemotherapy concepts and the role of the pioneers of medical oncology in the design of the various phases of drug trials, using childhood acute leukemia and breast cancer as models, are discussed. Over a short time and with only a few drugs, principles of chemotherapy were laid out, which led to cures in such diseases as childhood acute leukemia and Hodgkin's disease and to improved disease-free survival in breast cancer. It is these and other achievements that paved the way to medical oncology. At the instigation of the American Society of Clinical Oncology (ASCO), the American Board of Internal Medicine made inquiries about a subspecialty in oncology. ASCO and B. J. Kennedy, MD, played key roles in the events leading to the official recognition of medical oncology as a new subspecialty of internal medicine in 1972.
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Schutte, Tim; van Eekeren, Rike; Richir, Milan; van Staveren, Jojanneke; van Puijenbroek, Eugène; Tichelaar, Jelle; van Agtmael, Michiel
2018-01-01
In a new prescribing qualification course for specialist oncology nurses, we thought that it is important to emphasize pharmacovigilance and adverse drug reaction (ADR) reporting. We aimed to develop and evaluate an ADR reporting assignment for specialist oncology nurses. The quality of report documentation was assessed with the "Clinical Documentation tool to assess Individual Case Safety Reports" (ClinDoc). The relevance of the reports was evaluated in terms of ADR seriousness, the listing for additional monitoring of the drug by European Medicines Agency (EMA), and lack of labelling information about the ADR. Nurses' opinions of the assignment were evaluated using an E-survey. Thirty-three ADRs were reported, 32 (97%) of which were well documented according to ClinDoc. Thirteen ADRs (39%) were "serious" according to CIOMS criteria. In five cases (15%), the suspect drugs were listed for additional monitoring by EMA and in seven cases (21%), the ADR was not mentioned in the Summary of Product Characteristics. Twenty-five (78.1%) of the 32 enrolled nurses completed the E-survey. Most were > 45 years of age (68%), female (92%) and had extensive clinical experience (6-33 years). All agreed or completely agreed that the reporting assignment was useful, that it fitted in daily practice and that it increased their attention for medication/patient safety. A large majority (84.0%) agreed the assignment changed how they dealt with ADRs. Specialist oncology nurses are capable of reporting ADRs, and they considered the assignment useful. The assignment yielded valuable, relevant, and well-documented ADR reports for pharmacovigilance practice.
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Companion diagnostics and molecular imaging-enhanced approaches for oncology clinical trials.
Van Heertum, Ronald L; Scarimbolo, Robert; Ford, Robert; Berdougo, Eli; O'Neal, Michael
2015-01-01
In the era of personalized medicine, diagnostic approaches are helping pharmaceutical and biotechnology sponsors streamline the clinical trial process. Molecular assays and diagnostic imaging are routinely being used to stratify patients for treatment, monitor disease, and provide reliable early clinical phase assessments. The importance of diagnostic approaches in drug development is highlighted by the rapidly expanding global cancer diagnostics market and the emergent attention of regulatory agencies worldwide, who are beginning to offer more structured platforms and guidance for this area. In this paper, we highlight the key benefits of using companion diagnostics and diagnostic imaging with a focus on oncology clinical trials. Nuclear imaging using widely available radiopharmaceuticals in conjunction with molecular imaging of oncology targets has opened the door to more accurate disease assessment and the modernization of standard criteria for the evaluation, staging, and treatment responses of cancer patients. Furthermore, the introduction and validation of quantitative molecular imaging continues to drive and optimize the field of oncology diagnostics. Given their pivotal role in disease assessment and treatment, the validation and commercialization of diagnostic tools will continue to advance oncology clinical trials, support new oncology drugs, and promote better patient outcomes.
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78 FR 63224 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting
2013-10-23
... treatment of Mucopolysaccharidosis Type IVA (Morquio A syndrome). Morquio A syndrome is a rare congenital... Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate...Committees/Calendar/default.htm . Scroll down to the appropriate advisory committee meeting link. Procedure...
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Energy Technology Data Exchange (ETDEWEB)
Ahmed, Awad A. [Sylvester Comprehensive Cancer Center University of Miami Health System, Miami, Florida (United States); Hwang, Wei-Ting [Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania (United States); Holliday, Emma B. [Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Chapman, Christina H.; Jagsi, Reshma [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Thomas, Charles R. [Department of Radiation Medicine, Knight Cancer Institute, Oregon Health & Science University, Portland, Oregon (United States); Deville, Curtiland, E-mail: cdeville@jhmi.edu [Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, Maryland (United States)
2017-05-01
Purpose: Our purpose was to assess comparative female representation trends for trainees and full-time faculty in the academic radiation oncology and hematology oncology workforce of the United States over 3 decades. Methods and Materials: Simple linear regression models with year as the independent variable were used to determine changes in female percentage representation per year and associated 95% confidence intervals for trainees and full-time faculty in each specialty. Results: Peak representation was 48.4% (801/1654) in 2013 for hematology oncology trainees, 39.0% (585/1499) in 2014 for hematology oncology full-time faculty, 34.8% (202/581) in 2007 for radiation oncology trainees, and 27.7% (439/1584) in 2015 for radiation oncology full-time faculty. Representation significantly increased for trainees and full-time faculty in both specialties at approximately 1% per year for hematology oncology trainees and full-time faculty and 0.3% per year for radiation oncology trainees and full-time faculty. Compared with radiation oncology, the rates were 3.84 and 2.94 times greater for hematology oncology trainees and full-time faculty, respectively. Conclusion: Despite increased female trainee and full-time faculty representation over time in the academic oncology physician workforce, radiation oncology is lagging behind hematology oncology, with trainees declining in recent years in radiation oncology; this suggests a de facto ceiling in female representation. Whether such issues as delayed or insufficient exposure, inadequate mentorship, or specialty competitiveness disparately affect female representation in radiation oncology compared to hematology oncology are underexplored and require continued investigation to ensure that the future oncologic physician workforce reflects the diversity of the population it serves.
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International Nuclear Information System (INIS)
Ahmed, Awad A.; Hwang, Wei-Ting; Holliday, Emma B.; Chapman, Christina H.; Jagsi, Reshma; Thomas, Charles R.; Deville, Curtiland
2017-01-01
Purpose: Our purpose was to assess comparative female representation trends for trainees and full-time faculty in the academic radiation oncology and hematology oncology workforce of the United States over 3 decades. Methods and Materials: Simple linear regression models with year as the independent variable were used to determine changes in female percentage representation per year and associated 95% confidence intervals for trainees and full-time faculty in each specialty. Results: Peak representation was 48.4% (801/1654) in 2013 for hematology oncology trainees, 39.0% (585/1499) in 2014 for hematology oncology full-time faculty, 34.8% (202/581) in 2007 for radiation oncology trainees, and 27.7% (439/1584) in 2015 for radiation oncology full-time faculty. Representation significantly increased for trainees and full-time faculty in both specialties at approximately 1% per year for hematology oncology trainees and full-time faculty and 0.3% per year for radiation oncology trainees and full-time faculty. Compared with radiation oncology, the rates were 3.84 and 2.94 times greater for hematology oncology trainees and full-time faculty, respectively. Conclusion: Despite increased female trainee and full-time faculty representation over time in the academic oncology physician workforce, radiation oncology is lagging behind hematology oncology, with trainees declining in recent years in radiation oncology; this suggests a de facto ceiling in female representation. Whether such issues as delayed or insufficient exposure, inadequate mentorship, or specialty competitiveness disparately affect female representation in radiation oncology compared to hematology oncology are underexplored and require continued investigation to ensure that the future oncologic physician workforce reflects the diversity of the population it serves.
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Ahmed, Awad A; Hwang, Wei-Ting; Holliday, Emma B; Chapman, Christina H; Jagsi, Reshma; Thomas, Charles R; Deville, Curtiland
2017-05-01
Our purpose was to assess comparative female representation trends for trainees and full-time faculty in the academic radiation oncology and hematology oncology workforce of the United States over 3 decades. Simple linear regression models with year as the independent variable were used to determine changes in female percentage representation per year and associated 95% confidence intervals for trainees and full-time faculty in each specialty. Peak representation was 48.4% (801/1654) in 2013 for hematology oncology trainees, 39.0% (585/1499) in 2014 for hematology oncology full-time faculty, 34.8% (202/581) in 2007 for radiation oncology trainees, and 27.7% (439/1584) in 2015 for radiation oncology full-time faculty. Representation significantly increased for trainees and full-time faculty in both specialties at approximately 1% per year for hematology oncology trainees and full-time faculty and 0.3% per year for radiation oncology trainees and full-time faculty. Compared with radiation oncology, the rates were 3.84 and 2.94 times greater for hematology oncology trainees and full-time faculty, respectively. Despite increased female trainee and full-time faculty representation over time in the academic oncology physician workforce, radiation oncology is lagging behind hematology oncology, with trainees declining in recent years in radiation oncology; this suggests a de facto ceiling in female representation. Whether such issues as delayed or insufficient exposure, inadequate mentorship, or specialty competitiveness disparately affect female representation in radiation oncology compared to hematology oncology are underexplored and require continued investigation to ensure that the future oncologic physician workforce reflects the diversity of the population it serves. Copyright © 2017 Elsevier Inc. All rights reserved.
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Oncology Advanced Practitioners Bring Advanced Community Oncology Care.
Vogel, Wendy H
2016-01-01
Oncology care is becoming increasingly complex. The interprofessional team concept of care is necessary to meet projected oncology professional shortages, as well as to provide superior oncology care. The oncology advanced practitioner (AP) is a licensed health care professional who has completed advanced training in nursing or pharmacy or has completed training as a physician assistant. Oncology APs increase practice productivity and efficiency. Proven to be cost effective, APs may perform varied roles in an oncology practice. Integrating an AP into an oncology practice requires forethought given to the type of collaborative model desired, role expectations, scheduling, training, and mentoring.
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Pharmacogenetics in the oncological clinical practice
International Nuclear Information System (INIS)
Gruber, S.
2004-01-01
The genetic control of drug metabolism allows new insights into the bioavailability, toxicity, and efficacy of chemotherapy. In addition, molecular expression profiles of tumors offers the potential for targeted therapy to be directed more specifically to the biologic behavior of the cancer. Together these strategies are likely to change the practice of clinical oncology. However, appropriate clinical trials will be required to demonstrate the utility of these approaches before they are broadly implemented the biologic behavior of the cancer. Together these strategies are likely to change the practice of clinical oncology. However, appropriate clinical trials will be required to demonstrate the utility of these approaches before they are broadly implemented
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Report on the international colloquium on cardio-oncology (rome, 12-14 march 2014)
Ewer, Michael; Gianni, Luca; Pane, Fabrizio; Sandri, Maria Teresa; Steiner, Rudolf K.; Wojnowski, Leszek; Yeh, Edward T.; Carver, Joseph R.; Lipshultz, Steven E.; Minotti, Giorgio; Armstrong, Gregory T.; Cardinale, Daniela; Colan, Steven D.; Darby, Sarah C.; Force, Thomas L.; Kremer, Leontien C. M.; Lenihan, Daniel J.; Sallan, Stephen E.; Sawyer, Douglas B.; Suter, Thomas M.; Swain, Sandra M.; van Leeuwen, Flora E.
2014-01-01
Cardio-oncology is a relatively new discipline that focuses on the cardiovascular sequelae of anti-tumour drugs. As any other young adolescent discipline, cardio-oncology struggles to define its scientific boundaries and to identify best standards of care for cancer patients or survivors at risk of
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78 FR 60884 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
2013-10-02
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Immunoregulation, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics...
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76 FR 13646 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
2011-03-14
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Polysaccharides, Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review...
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76 FR 44016 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
2011-07-22
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research...
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Cancer Patients and Oncology Nursing: Perspectives of Oncology ...
African Journals Online (AJOL)
Background and Aim: Burnout and exhaustion is a frequent problem in oncology nursing. The aim of this study is to evaluate the aspects of oncology nurses about their profession in order to enhance the standards of oncology nursing. Materials and Methods: This survey was conducted with 70 oncology nurses working at ...
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International Nuclear Information System (INIS)
Connor, Michael J.; Marshall, Deborah C.; Moiseenko, Vitali; Moore, Kevin; Cervino, Laura; Atwood, Todd; Sanghvi, Parag; Mundt, Arno J.; Pawlicki, Todd; Recht, Abram; Hattangadi-Gluth, Jona A.
2017-01-01
Purpose: Radiation oncology relies on rapidly evolving technology and highly complex processes. The US Food and Drug Administration collects reports of adverse events related to medical devices. We sought to characterize all events involving radiation oncology devices (RODs) from the US Food and Drug Administration's postmarket surveillance Manufacturer and User Facility Device Experience (MAUDE) database, comparing these with non–radiation oncology devices. Methods and Materials: MAUDE data on RODs from 1991 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems) and 5 device problem categories (software, mechanical, electrical, user error, and dose delivery impact). Outcomes included whether the device was evaluated by the manufacturer, adverse event type, remedial action, problem code, device age, and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by the Pearson χ"2 test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions. Results: There were 4234 ROD and 4,985,698 other device adverse event reports. Adverse event reports increased over time, and events involving RODs peaked in 2011. Most ROD reports involved external beam therapy (50.8%), followed by brachytherapy (24.9%) and treatment planning systems (21.6%). The top problem types were software (30.4%), mechanical (20.9%), and user error (20.4%). RODs differed significantly from other devices in each outcome (P<.001). RODs were more likely to be evaluated by the manufacturer after an event (46.9% vs 33.0%) but less likely to be recalled (10.5% vs 37.9%) (P<.001). Device age and time since 510(k) approval were shorter among RODs (P<.001). Conclusions: Compared with other devices, RODs may experience adverse events sooner after manufacture and market approval. Close postmarket surveillance, improved
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Energy Technology Data Exchange (ETDEWEB)
Connor, Michael J. [Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California (United States); Department of Radiation Oncology, University of California Irvine School of Medicine, Irvine, California (United States); Marshall, Deborah C.; Moiseenko, Vitali; Moore, Kevin; Cervino, Laura; Atwood, Todd; Sanghvi, Parag; Mundt, Arno J.; Pawlicki, Todd [Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California (United States); Recht, Abram [Department of Radiation Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (United States); Hattangadi-Gluth, Jona A., E-mail: jhattangadi@ucsd.edu [Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California (United States)
2017-01-01
Purpose: Radiation oncology relies on rapidly evolving technology and highly complex processes. The US Food and Drug Administration collects reports of adverse events related to medical devices. We sought to characterize all events involving radiation oncology devices (RODs) from the US Food and Drug Administration's postmarket surveillance Manufacturer and User Facility Device Experience (MAUDE) database, comparing these with non–radiation oncology devices. Methods and Materials: MAUDE data on RODs from 1991 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems) and 5 device problem categories (software, mechanical, electrical, user error, and dose delivery impact). Outcomes included whether the device was evaluated by the manufacturer, adverse event type, remedial action, problem code, device age, and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by the Pearson χ{sup 2} test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions. Results: There were 4234 ROD and 4,985,698 other device adverse event reports. Adverse event reports increased over time, and events involving RODs peaked in 2011. Most ROD reports involved external beam therapy (50.8%), followed by brachytherapy (24.9%) and treatment planning systems (21.6%). The top problem types were software (30.4%), mechanical (20.9%), and user error (20.4%). RODs differed significantly from other devices in each outcome (P<.001). RODs were more likely to be evaluated by the manufacturer after an event (46.9% vs 33.0%) but less likely to be recalled (10.5% vs 37.9%) (P<.001). Device age and time since 510(k) approval were shorter among RODs (P<.001). Conclusions: Compared with other devices, RODs may experience adverse events sooner after manufacture and market approval. Close postmarket surveillance
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21 CFR 14.40 - Establishment and renewal of advisory committees.
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Establishment and renewal of advisory committees. 14.40 Section 14.40 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN..., color, national origin, religion, age, or sex. (3) It is constituted and utilizes procedures designed to...
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Targeted drugs and Psycho-oncological intervention for breast cancer patients.
D'Abramo, Flavio; Goerling, Ute; Guastadisegni, Cecilia
2016-04-01
Personalized medicine is a new field based on molecular biology and genomics in which targeted tumor therapies are administered to patients. Psycho-oncology is a complementary approach that considers social and psychological aspects of patients as part of the treatments for cancer patients. The aim of this mini-review is to weigh clinical benefits for breast cancer patients of both treatments and possibly enhance benefits by modulating the use of both interventions. We have compared and evaluated on the one hand the use of anti Vascular Endothelial Growth Factor and, on the other hand, psycho-oncological interventions in metastatic and non-metastatic breast cancer patients.Both treatments did not increase survival of metastatic breast cancer patients, while in a selected study psycho-oncological interventions extended lifespan of non-metastatic breast cancer patients and ameliorate psychological and social factors of metastatic breast cancer patients. Because the two approaches address completely different aspects of cancer patients, if the comparison is limited to the extension of survival, the value of these two treatments cannot be assessed and compared.It is likely that by comparing patients reported outcomes, possibly by using standardized Quality of Life questionnaires, both patients and health care providers can weigh the benefits of the two treatments. It is therefore important to evaluate the use of cancer patients' quality of life measures as a mean to improve their experiences about life and treatment, and possibly to extend their survival.
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77 FR 42319 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
2012-07-18
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide... consideration of the appropriateness of cell lines derived from human tumors for vaccine manufacture. FDA...
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77 FR 3780 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
2012-01-25
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. The...
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75 FR 59729 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
2010-09-28
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... vaccines for a post-exposure prophylaxis indication using the animal rule. On November 17, 2010, the...
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78 FR 20663 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
2013-04-05
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function..., Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. FDA intends to...
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76 FR 55397 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
2011-09-07
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Laboratory of Method Development, Division of Viral Products, Office of Vaccines Research and Review, Center...
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2010-03-11
...] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General... Pharmaceutical Science (OPS) on the regulatory challenges of drug-induced phospholipidosis (excessive...
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Cobb, Susan C.; Baird, Susan B.
1999-01-01
A survey to determine whether oncology nurses (n=670) use the Internet and for what purpose revealed that they use it for drug information, literature searches, academic information, patient education, and continuing education. Results suggest that continuing-education providers should pursue the Internet as a means of meeting the need for quick,…
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21 CFR 14.35 - Written submissions to an advisory committee.
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Written submissions to an advisory committee. 14.35 Section 14.35 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... of the written summary along with a proposed agenda outlining the topics to be covered and...
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77 FR 63839 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
2012-10-17
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide...) Virus Monovalent Vaccine manufactured by GlaxoSmithKline. On November 15, 2012, the committee will meet...
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75 FR 2876 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
2010-01-19
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide... virus vaccine for the 2010 - 2011 influenza season. FDA intends to make background material available to...
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76 FR 3639 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
2011-01-20
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide... the influenza virus vaccine for the 2011-2012 influenza season. The committee will also hear an update...
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78 FR 5465 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
2013-01-25
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide... virus vaccine for the 2013- 2014 influenza season. FDA intends to make background material available to...
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78 FR 44133 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
2013-07-23
...] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide... documents issued from the Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and...
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76 FR 22405 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
2011-04-21
...] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide... June 29, 2011, the committee will discuss cellular and gene therapy products for the treatment of...
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78 FR 79699 - Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting
2013-12-31
...] Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Cellular, Tissue, and Gene Therapies Advisory Committee. General Function of the Committee: To provide... updates on guidance documents issued from the Office of Cellular, Tissue, and Gene Therapies, Center for...
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2010-03-08
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
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2011-01-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
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2013-07-18
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
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2012-07-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
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2012-07-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
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2012-01-11
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
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2010-02-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0067] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
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Report on the International Colloquium on Cardio-Oncology (Rome, 12–14 March 2014)
Ewer, Michael; Gianni, Luca; Pane, Fabrizio; Sandri, Maria Teresa; Steiner, Rudolf K; Wojnowski, Leszek; Yeh, Edward T; Carver, Joseph R; Lipshultz, Steven E; Minotti, Giorgio; Armstrong, Gregory T; Cardinale, Daniela; Colan, Steven D; Darby, Sarah C; Force, Thomas L; Kremer, Leontien CM; Lenihan, Daniel J; Sallan, Stephen E; Sawyer, Douglas B; Suter, Thomas M; Swain, Sandra M; van Leeuwen, Flora E
2014-01-01
Cardio-oncology is a relatively new discipline that focuses on the cardiovascular sequelae of anti-tumour drugs. As any other young adolescent discipline, cardio-oncology struggles to define its scientific boundaries and to identify best standards of care for cancer patients or survivors at risk of cardiovascular events. The International Colloquium on Cardio-Oncology was held in Rome, Italy, 12–14 March 2014, with the aim of illuminating controversial issues and unmet needs in modern cardio-oncology. This colloquium embraced contributions from different kind of disciplines (oncology and cardiology but also paediatrics, geriatrics, genetics, and translational research); in fact, cardio-oncology goes way beyond the merging of cardiology with oncology. Moreover, the colloquium programme did not review cardiovascular toxicity from one drug or the other, rather it looked at patients as we see them in their fight against cancer and eventually returning to everyday life. This represents the melting pot in which anti-cancer therapies, genetic backgrounds, and risk factors conspire in producing cardiovascular sequelae, and this calls for screening programmes and well-designed platforms of collaboration between one key professional figure and another. The International Colloquium on Cardio-Oncology was promoted by the Menarini International Foundation and co-chaired by Giorgio Minotti (Rome), Joseph R Carver (Philadelphia, Pennsylvania, United States), and Steven E Lipshultz (Detroit, Michigan, United States). The programme was split into five sessions of broad investigational and clinical relevance (what is cardiotoxicity?, cardiotoxicity in children, adolescents, and young adults, cardiotoxicity in adults, cardiotoxicity in special populations, and the future of cardio-oncology). Here, the colloquium chairs and all the session chairs briefly summarised what was said at the colloquium. Topics and controversies were reported on behalf of all members of the working group
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Tumor Slice Culture: A New Avatar in Personalized Oncology
2017-08-01
Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden...Achilles heel of personalized oncology. The objective of this proposal is to establish a robust, efficient, reproducible platform to interrogate drug...establish a robust, efficient, reproducible platform to interrogate the response of a given tumor to drugs (cytotoxics, kinase inhibitors, immune
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78 FR 70954 - Risk Communications Advisory Committee; Notice of Meeting
2013-11-27
... awareness and understanding of the key risk messages, as well as whether the communications are having the... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Risk Communications Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...
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76 FR 59404 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting
2011-09-26
..., efficacy, and durability of response with repeat treatment cycles of XIFAXAN (rifaximin), by Salix Pharmaceuticals, Inc., for irritable bowel syndrome with diarrhea. FDA intends to make background material...Committees/Calendar/default.htm . Scroll down to the appropriate advisory committee link. Procedure...
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78 FR 48438 - Pediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice of Meeting
2013-08-08
...] Pediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice of Meeting AGENCY: Food and Drug... of Subcommittee: Pediatric Ethics Subcommittee of the Pediatric Advisory Committee. General Function... pediatric ethical issues. Date and Time: The meeting will be held on September 9, 2013, from 8 a.m. to 5:30...
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21 CFR 14.20 - Notice of hearing before an advisory committee.
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Notice of hearing before an advisory committee. 14.20 Section 14.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... function of the committee; (4) A list of all agenda items, showing whether each will be discussed in an...
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78 FR 69991 - Advisory Committee; Veterinary Medicine Advisory Committee; Termination
2013-11-22
.... FDA-2013-N-1380] Advisory Committee; Veterinary Medicine Advisory Committee; Termination AGENCY: Food... announcing the termination of the Veterinary Medicine Advisory Committee. This document removes the Veterinary Advisory Committee from the Agency's list of standing advisory committees. DATES: This rule is...
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Impact of radiation research on clinical trials in radiation oncology
International Nuclear Information System (INIS)
Rubin, P.; Van Ess, J.D.
1989-01-01
The authors present an outline review of the history of the formation of the cooperative group called International Clinical Trials in Radiation Oncology (ICTRO), and the following areas are briefly discussed together with some projections for the direction of clinical trials in radiation oncology into the 1990s:- radiosensitizers, radioprotectors, and their combination, drug-radiation interactions, dose/time/fractionation, hyperthermia, biological response modifiers and radiolabelled antibodies, high LET, particularly neutron therapy, large field irradiation and interoperative irradiation, research studies on specific sites. (U.K.)
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Directory of Open Access Journals (Sweden)
Calvin Chen Sheng, MD
2016-08-01
Full Text Available Cardiotoxicity is a well-established complication of oncology therapies. Cardiomyopathy resulting from anthracyclines is a classic example. In the past decade, an explosion of novel cancer therapies, often targeted and more specific than conventional therapies, has revolutionized oncology therapy and dramatically changed cancer prognosis. However, some of these therapies have introduced an assortment of cardiovascular (CV complications. At times, these devastating outcomes have only become apparent after drug approval and have limited the use of potent therapies. There is a growing need for better testing platforms, both for CV toxicity screening and for elucidating mechanisms of cardiotoxicities of approved cancer therapies. This review discusses the utility of available nonclinical models (in vitro, in vivo, and in silico and highlights recent advancements in modalities like human stem cell-derived cardiomyocytes for developing more comprehensive cardiotoxicity testing and new means of cardioprotection with targeted anticancer therapies.
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78 FR 27971 - Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting
2013-05-13
...] Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Dental Products Panel of the Medical Devices Advisory Committee. General Function of the Committee: To... regulatory classification for dental devices known as Endosseous Dental Implants (Blade-form), one of the...
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Community oncology in an era of payment reform.
Cox, John V; Ward, Jeffery C; Hornberger, John C; Temel, Jennifer S; McAneny, Barbara L
2014-01-01
Patients and payers (government and private) are frustrated with the fee-for-service system (FFS) of payment for outpatient health services. FFS rewards volume and highly valued services, including expensive diagnostics and therapeutics, over lesser valued cognitive services. Proposed payment schemes would incent collaboration and coordination of care among providers and reward quality. In oncology, new payment schemes must address the high costs of all services, particularly drugs, while preserving the robust distribution of sites of service available to patients in the United States. Information technology and personalized cancer care are changing the practice of oncology. Twenty-first century oncology will require increasing cognitive work and shared decision making, both of which are not well regarded in the FFS model. A high proportion of health care dollars are consumed in the final months of life. Effective delivery of palliative and end-of-life care must be addressed by practice and by new models of payment. Value-based reimbursement schemes will require oncology practices to change how they are structured. Lessons drawn from the principles of primary care's Patient Centered Medical Home (PCMH) will help oncology practice to prepare for new schemes. PCMH principles place a premium on proactively addressing toxicities of therapies, coordinating care with other providers, and engaging patients in shared decision making, supporting the ideal of value defined in the triple aim-to measurably improve patient experience and quality of care at less cost. Payment reform will be disruptive to all. Oncology must be engaged in policy discussions and guide rational shifts in priorities defined by new payment models.
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Payment Reform: Unprecedented and Evolving Impact on Gynecologic Oncology.
Apte, Sachin M; Patel, Kavita
2016-01-01
With the signing of the Medicare Access and CHIP Reauthorization Act in April 2015, the Centers for Medicare and Medicaid Services (CMS) is now positioned to drive the development and implementation of sweeping changes to how physicians and hospitals are paid for the provision of oncology-related services. These changes will have a long-lasting impact on the sub-specialty of gynecologic oncology, regardless of practice structure, physician employment and compensation model, or local insurance market. Recently, commercial payers have piloted various models of payment reform via oncology-specific clinical pathways, oncology medical homes, episode payment arrangements, and accountable care organizations. Despite the positive results of some pilot programs, adoption remains limited. The goals are to eliminate unnecessary variation in cancer treatment, provide coordinated patient-centered care, while controlling costs. Yet, meaningful payment reform in oncology remains elusive. As the largest payer for oncology services in the United States, CMS has the leverage to make cancer services more value based. Thus far, the focus has been around pricing of physician-administered drugs with recent work in the area of the Oncology Medical Home. Gynecologic oncology is a unique sub-specialty that blends surgical and medical oncology, with treatment that often involves radiation therapy. This forward-thinking, multidisciplinary model works to keep the patient at the center of the care continuum and emphasizes care coordination. Because of the breadth and depth of gynecologic oncology, this sub-specialty has both the potential to be disrupted by payment reform as well as potentially benefit from the aspects of reform that can align incentives appropriately to improve coordination. Although the precise future payment models are unknown at this time, focused engagement of gynecologic oncologists and the full care team is imperative to assure that the practice remains patient centered
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Payment Reform: Unprecedented and Evolving Impact on Gynecologic Oncology
Apte, Sachin M.; Patel, Kavita
2016-01-01
With the signing of the Medicare Access and CHIP Reauthorization Act in April 2015, the Centers for Medicare and Medicaid Services (CMS) is now positioned to drive the development and implementation of sweeping changes to how physicians and hospitals are paid for the provision of oncology-related services. These changes will have a long-lasting impact on the sub-specialty of gynecologic oncology, regardless of practice structure, physician employment and compensation model, or local insurance market. Recently, commercial payers have piloted various models of payment reform via oncology-specific clinical pathways, oncology medical homes, episode payment arrangements, and accountable care organizations. Despite the positive results of some pilot programs, adoption remains limited. The goals are to eliminate unnecessary variation in cancer treatment, provide coordinated patient-centered care, while controlling costs. Yet, meaningful payment reform in oncology remains elusive. As the largest payer for oncology services in the United States, CMS has the leverage to make cancer services more value based. Thus far, the focus has been around pricing of physician-administered drugs with recent work in the area of the Oncology Medical Home. Gynecologic oncology is a unique sub-specialty that blends surgical and medical oncology, with treatment that often involves radiation therapy. This forward-thinking, multidisciplinary model works to keep the patient at the center of the care continuum and emphasizes care coordination. Because of the breadth and depth of gynecologic oncology, this sub-specialty has both the potential to be disrupted by payment reform as well as potentially benefit from the aspects of reform that can align incentives appropriately to improve coordination. Although the precise future payment models are unknown at this time, focused engagement of gynecologic oncologists and the full care team is imperative to assure that the practice remains patient centered
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Payment Reform: Unprecedented and Evolving Impact on Gynecologic Oncology
Directory of Open Access Journals (Sweden)
Sachin eApte
2016-04-01
Full Text Available With the signing of the Medicare Access and CHIP Reauthorization Act (MACRA in April 2015, the Centers for Medicare and Medicaid Services (CMS is now positioned to drive the development and implementation of sweeping changes to how physicians and hospitals are paid for the provision of oncology related services. These changes will have a long-lasting impact on the sub-specialty of gynecologic oncology, regardless of practice structure, physician employment and compensation model, or local insurance market. Recently, commercial payers have piloted various models of payment reform via oncology specific clinical pathways, oncology medical homes, episode payment arrangements, and accountable care organizations. Despite the positive results of some pilot programs, adoption remains limited. The goals are to eliminate unnecessary variation in cancer treatment, provide coordinated patient-centered care, while controlling costs. Yet, meaningful payment reform in oncology remains elusive. As the largest payer for oncology services in the United States, CMS has the leverage to make cancer services more value-based. Thus far, the focus has been around pricing of physician-administered drugs with recent work in the area of the Oncology Medical Home. Gynecologic oncology is a unique sub-specialty which blends surgical and medical oncology, with treatment that often involves radiation therapy. This forward-thinking, multi-disciplinary model works to keep the patient at the center of the care continuum and emphasizes care coordination. Because of the breadth and depth of gynecologic oncology, this sub-specialty has both the potential to be disrupted by payment reform as well as potentially benefit from the aspects of reform which can align incentives appropriately to improve coordination. Although the precise future payment models are unknown at this time, focused engagement of gynecologic oncologists and the full care team is imperative to assure that the
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Stahel, R; Bogaerts, J; Ciardiello, F; de Ruysscher, D; Dubsky, P; Ducreux, M; Finn, S; Laurent-Puig, P; Peters, S; Piccart, M; Smit, E; Sotiriou, C; Tejpar, S; Van Cutsem, E; Tabernero, J
2015-02-01
Despite intense efforts, the socioeconomic burden of cancer remains unacceptably high and treatment advances for many common cancers have been limited, suggesting a need for a new approach to drug development. One issue central to this lack of progress is the heterogeneity and genetic complexity of many tumours. This results in considerable variability in therapeutic response and requires knowledge of the molecular profile of the tumour to guide appropriate treatment selection for individual patients. While recent advances in the molecular characterisation of different cancer types have the potential to transform cancer treatment through precision medicine, such an approach presents a major economic challenge for drug development, since novel targeted agents may only be suitable for a small cohort of patients. Identifying the patients who would benefit from individual therapies and recruiting sufficient numbers of patients with particular cancer subtypes into clinical trials is challenging, and will require collaborative efforts from research groups and industry in order to accelerate progress. A number of molecular screening platforms have already been initiated across Europe, and it is hoped that these networks, along with future collaborations, will benefit not only patients but also society through cost reductions as a result of more efficient use of resources. This review discusses how current developments in translational oncology may be applied in clinical practice in the future, assesses current programmes for the molecular characterisation of cancer and describes possible collaborative approaches designed to maximise the benefits of translational science for patients with cancer. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.
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Polypharmacology of Approved Anticancer Drugs.
Amelio, Ivano; Lisitsa, Andrey; Knight, Richard A; Melino, Gerry; Antonov, Alexey V
2017-01-01
The major drug discovery efforts in oncology have been concentrated on the development of selective molecules that are supposed to act specifically on one anticancer mechanism by modulating a single or several closely related drug targets. However, a bird's eye view on data from multiple available bioassays implies that most approved anticancer agents do, in fact, target many more proteins with different functions. Here we will review and systematize currently available information on the targets of several anticancer drugs along with revision of their potential mechanisms of action. Polypharmacology of the current antineoplastic agents suggests that drug clinical efficacy in oncology can be achieved only via modulation of multiple cellular mechanisms. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.
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International Nuclear Information System (INIS)
Bragg, D.G.; Rubin, P.; Youker, J.E.
1985-01-01
This book presents papers on nuclear medicine. Topics considered include the classification of cancers, oncologic diagnosis, brain and spinal cord neoplasms, lymph node metastases, the larynx and hypopharynx, thyroid cancer, breast cancer, esophageal cancer, bladder cancer, tumors of the skeletal system, pediatric oncology, computed tomography and radiation therapy treatment planning, and the impact of future technology on oncologic diagnosis
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77 FR 50701 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting
2012-08-22
... always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down... (teduglutide) for subcutaneous injection, by NPS Pharmaceuticals, Inc, for the proposed indication of treatment of adult patients with short bowel syndrome. FDA intends to make background material available to the...
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2012-03-28
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory...
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2011-11-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory...
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2011-09-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of Meeting AGENCY... postponing the meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee scheduled...
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International Nuclear Information System (INIS)
Beyzadeoglu, M. M.; Ebruli, C.
2008-01-01
Basic Radiation Oncology is an all-in-one book. It is an up-to-date bedside oriented book integrating the radiation physics, radiobiology and clinical radiation oncology. It includes the essentials of all aspects of radiation oncology with more than 300 practical illustrations, black and white and color figures. The layout and presentation is very practical and enriched with many pearl boxes. Key studies particularly randomized ones are also included at the end of each clinical chapter. Basic knowledge of all high-tech radiation teletherapy units such as tomotherapy, cyberknife, and proton therapy are also given. The first 2 sections review concepts that are crucial in radiation physics and radiobiology. The remaining 11 chapters describe treatment regimens for main cancer sites and tumor types. Basic Radiation Oncology will greatly help meeting the needs for a practical and bedside oriented oncology book for residents, fellows, and clinicians of Radiation, Medical and Surgical Oncology as well as medical students, physicians and medical physicists interested in Clinical Oncology. English Edition of the book Temel Radyasyon Onkolojisi is being published by Springer Heidelberg this year with updated 2009 AJCC Staging as Basic Radiation Oncology
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Challenges in Measuring Cost and Value in Oncology: Making It Personal.
Yu, Peter P
2016-01-01
Oncology patients often find themselves facing an incurable disease with limited treatment options and increasing patient fragility. The importance of patient preferences and values increases in shared decision making especially when the cost of cancer care is continuing its steep rise. As our understanding of cancer systems biology increases, we are justifiably optimistic about therapeutic improvements but recognize that this has complicated the traditional Food and Drug Administration approval of drug indications based on organ-specific cancer for a particular drug. Dynamic and agile clinical guidelines that reflect a rapidly changing knowledge base for decision-making support are needed. The American Society of Clinical Oncology (ASCO) has been working on three initiatives to tackle these complex issues. The first initiative is ASCO's collaboration with other international organizations to create a framework to assess drugs for the World Health Organization's Essential Medicines List, including nongenerics. The second initiative aims to define clinically meaningful outcomes as precision medicine expands the definition of cancers, leading to increased demand for the use of targeted drugs as single agents or in combination. The third initiative is ASCO's value framework, published in 2015, focusing on patient-physician shared decision making. The framework incorporates three parameters: 1) the meaningfulness of the clinical benefit, 2) the toxicity of the treatment, and 3) the patient's financial out-of-pocket cost. ASCO is concerned about the rising cost of cancer care when the clinical complexity and the pace of change in oncology are accelerating, and it is committed to help improve patient outcomes and value in cancer care as well as to engage the broader health care community in a process of collaborative improvement. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.
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2011-02-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0066] Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Molecular and Clinical Genetics Panel of the Medical Devices Advisory...
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2010-08-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee scheduled for August...
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2013-04-30
..., USA, Inc., Oncology Care Systems (Radiation Oncology), Including On-Site Leased Workers From Source... Medical Solutions, USA, Inc., Oncology Care Systems (Radiation Oncology), including on- site leased... of February 2013, Siemens Medical Solutions, USA, Inc., Oncology Care Systems (Radiation Oncology...
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Cancer patients and oncology nursing: Perspectives of oncology nurses in Turkey.
Kamisli, S; Yuce, D; Karakilic, B; Kilickap, S; Hayran, M
2017-09-01
Burnout and exhaustion is a frequent problem in oncology nursing. The aim of this study is to evaluate the aspects of oncology nurses about their profession in order to enhance the standards of oncology nursing. This survey was conducted with 70 oncology nurses working at Hacettepe University Oncology Hospital. Data were collected between January-April 2012. Each participant provided a study form comprising questions about sociodemographic information; about difficulties, positive aspects and required skills for oncology nursing; and questions evaluating level of participation and clinical perception of oncology nursing. Mean age of nurses was 29.9 ± 5.7 years. More than half of the participants were married (51.4%) and 30% had at least one child. Percent of nurses working in oncology for their entire work life was 75.8%. Most frequently expressed difficulties were exhaustion (58.6%), coping with the psychological problems of the patients (25.7%), and frequent deaths (24.3%); positive aspects were satisfaction (37.1%), changing the perceptions about life (30%), and empathy (14.3%); and required skills were patience (60%), empathy (57.1%), and experience (50%). For difficulties of oncology nursing, 28.3% of difficulties could be attributed to job-related factors, 30.3% to patient-related factors, and 77% of difficulties to individual factors. The independent predictors of participation level of the nurses were self-thoughts of skills and positive aspects of oncology nursing. According to the findings of this study, nurses declared that working with cancer patients increase burnout, they are insufficient in managing work stress and giving psychological care to patients, but their job satisfaction, clinical skills and awareness regarding priorities of life has increased.
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Dranitsaris, George; Ortega, Ana; Lubbe, Martie S; Truter, Ilse
2012-03-01
Several European governments have recently mandated price cuts in drugs to reduce health care spending. However, such measures without supportive evidence may compromise patient care because manufacturers may withdraw current products or not launch new agents. A value-based pricing scheme may be a better approach for determining a fair drug price and may be a medium for negotiations between the key stakeholders. To demonstrate this approach, pharmacoeconomic (PE) modeling was used from the Spanish health care system perspective to estimate a value-based price for bevacizumab, a drug that provides a 1.4-month survival benefit to patients with metastatic colorectal cancer (mCRC). The threshold used for economic value was three times the Spanish per capita GDP, as recommended by the World Health Organization (WHO). A PE model was developed to simulate outcomes in mCRC patients receiving chemotherapy ± bevacizumab. Clinical data were obtained from randomized trials and costs from a Spanish hospital. Utility estimates were determined by interviewing 24 Spanish oncology nurses and pharmacists. A price per dose of bevacizumab was then estimated using a target threshold of € 78,300 per quality-adjusted life year gained, which is three times the Spanish per capita GDP. For a 1.4-month survival benefit, a price of € 342 per dose would be considered cost effective from the Spanish public health care perspective. The price may be increased to € 733 or € 843 per dose if the drug were able to improve patient quality of life or enhance survival from 1.4 to 3 months. This study demonstrated that a value-based pricing approach using PE modeling and the WHO criteria for economic value is feasible and perhaps a better alternative to government mandated price cuts. The former approach would be a good starting point for opening dialog between European government payers and the pharmaceutical industry.
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Implementing Genome-Driven Oncology
Hyman, David M.; Taylor, Barry S.; Baselga, José
2017-01-01
Early successes in identifying and targeting individual oncogenic drivers, together with the increasing feasibility of sequencing tumor genomes, have brought forth the promise of genome-driven oncology care. As we expand the breadth and depth of genomic analyses, the biological and clinical complexity of its implementation will be unparalleled. Challenges include target credentialing and validation, implementing drug combinations, clinical trial designs, targeting tumor heterogeneity, and deploying technologies beyond DNA sequencing, among others. We review how contemporary approaches are tackling these challenges and will ultimately serve as an engine for biological discovery and increase our insight into cancer and its treatment. PMID:28187282
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Fernandes, G S; Sternberg, C; Lopes, G; Chammas, R; Gifoni, M A C; Gil, R A; Araujo, D V
2018-01-11
A biosimilar is a biologic product that is similar to a reference biopharmaceutical product, the manufacturing process of which hinders the ability to identically replicate the structure of the original product, and therefore, it cannot be described as an absolute equivalent of the original medication. The currently available technology does not allow for an accurate copy of complex molecules, but it does allow the replication of similar molecules with the same activity. As biosimilars are about to be introduced in oncology practice, these must be evaluated through evidence-based medicine. This manuscript is a position paper, where the Brazilian Society of Clinical Oncology (SBOC) aims to describe pertinent issues regarding the approval and use of biosimilars in oncology. As a working group on behalf of SBOC, we discuss aspects related to definition, labeling/nomenclature, extrapolation, interchangeability, switching, automatic substitution, clinical standards on safety and efficacy, and the potential impact on financial burden in healthcare. We take a stand in favor of the introduction of biosimilars, as they offer a viable, safe, and cost-effective alternative to the biopharmaceutical products currently used in cancer. We hope this document can provide valuable information to support therapeutic decisions that maximize the clinical benefit for the thousands of cancer patients in Brazil and can contribute to expedite the introduction of this new drug class in clinical practice. We expect the conveyed information to serve as a basis for further discussion in Latin America, this being the first position paper issued by a Latin American Oncology Society.
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van Leeuwen, R. W. F.; Jansman, F. G. A.; van den Bemt, P. M. L. A.; de Man, F.; Piran, F.; Vincenten, I.; Jager, A.; Rijneveld, A. W.; Brugma, J. D.; Mathijssen, R. H. J.; van Gelder, T.
Background: Drug-drug interactions (DDIs) are of major concern in oncology, since cancer patients typically take many concomitant medications. Retrospective studies have been conducted to determine the prevalence of DDIs. However, prospective studies on DDIs needing interventions in cancer patients
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Acute oncological emergencies.
LENUS (Irish Health Repository)
Gabriel, J
2012-01-01
The number of people receiving systemic anti-cancer treatment and presenting at emergency departments with treatment-related problems is rising. Nurses will be the first point of contact for most patients and need to be able to recognise oncological emergencies to initiate urgent assessment of patients and referral to the acute oncology team so that the most appropriate care can be delivered promptly. This article discusses the role of acute oncology services, and provides an overview of the most common acute oncological emergencies.
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Content analysis of oncology-related pharmaceutical advertising in a peer-reviewed medical journal.
Yonemori, Kan; Hirakawa, Akihiro; Ando, Masashi; Hirata, Taizo; Yunokawa, Mayu; Shimizu, Chikako; Tamura, Kenji; Fujiwara, Yasuhiro
2012-01-01
The oncology market represents one of the largest pharmaceutical markets in any medical field, and printed advertising in medical journals is an important channel by which pharmaceutical companies communicate with healthcare professionals. The aim of the present study was to analyze the volume and content of and trends and changes in oncology-related advertising intended for healthcare professionals in a peer-reviewed medical journal. Information that could be included in advertisements to promote drug development and improve treatment strategies for cancer patients is discussed on the basis of the results of the analysis. Overall, 6,720 advertisements covering 13,039 pages in a leading oncology medical journal published (by the American Society of Clinical Oncology) between January 2005 and December 2009 were analyzed. The advertisements targeting pharmaceuticals and clinical trials, in particular, were reviewed. A total of 6,720 advertisements covering 13,039 pages were included in the analysis. For the years 2005-2009, the percentages of total journal pages dedicated to advertising were 24.0%, 45.7%, 49.8%, 46.8%, and 49.8%, respectively. Package insert information and efficacy and safety explanations appeared in more than 80% of advertisements intended for pharmaceutical promotion. From 2005 to 2009, the overall quantity of drug advertisements decreased by approximately 13%, whereas advertisements calling for the enrollment of patients into registration trials increased by approximately 11%. Throughout the study period, oncology-related pharmaceutical advertisements occupied a considerable number of pages relative to other journal content. The proportion of advertisements on ongoing clinical trials increased progressively throughout the study period.
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21 CFR 14.155 - Fees and compensation pertaining to a color additive advisory committee.
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Fees and compensation pertaining to a color additive advisory committee. 14.155 Section 14.155 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... deposits and fees required by this section are to be paid by money order, bank draft, or certified check...
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Nanotechnology in Radiation Oncology
Wang, Andrew Z.; Tepper, Joel E.
2014-01-01
Nanotechnology, the manipulation of matter on atomic and molecular scales, is a relatively new branch of science. It has already made a significant impact on clinical medicine, especially in oncology. Nanomaterial has several characteristics that are ideal for oncology applications, including preferential accumulation in tumors, low distribution in normal tissues, biodistribution, pharmacokinetics, and clearance, that differ from those of small molecules. Because these properties are also well suited for applications in radiation oncology, nanomaterials have been used in many different areas of radiation oncology for imaging and treatment planning, as well as for radiosensitization to improve the therapeutic ratio. In this article, we review the unique properties of nanomaterials that are favorable for oncology applications and examine the various applications of nanotechnology in radiation oncology. We also discuss the future directions of nanotechnology within the context of radiation oncology. PMID:25113769
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Acute Thoracic Findings in Oncologic Patients.
Carter, Brett W; Erasmus, Jeremy J
2015-07-01
Cancer is the second most common cause of mortality in the United States, with >500,000 deaths reported annually. Acute or emergent findings in this group of patients can be a life-threatening phenomenon that results from malignancy or as a complication of therapy. In many cases, these events can be the first clinical manifestation of malignant disease. Oncologic emergencies have been classified as metabolic, hematologic, and structural emergencies. Within the thorax, most acute oncologic findings involve the lungs and airways in the form of drug toxicity, pulmonary infections, or malignant airway compression; the cardiovascular system in the form of pulmonary embolism, superior vena cava syndrome, cardiac tamponade, or massive hemoptysis; the mediastinum in the form of esophageal perforation, acute mediastinitis, or esophagorespiratory fistula; and the osseous spine and spinal cord in the form of invasion and cord compression. Given the life-threatening nature of many of these disease processes, awareness of such complications is critical to making an accurate diagnosis and formulating appropriate treatment strategies.
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Immuno-oncology combinations: raising the tail of the survival curve
International Nuclear Information System (INIS)
Harris, Samuel J.; Brown, Jessica; Lopez, Juanita; Yap, Timothy A.
2016-01-01
There have been exponential gains in immuno-oncology in recent times through the development of immune checkpoint inhibitors. Already approved by the U.S. Food and Drug Administration for advanced melanoma and non-small cell lung cancer, immune checkpoint inhibitors also appear to have significant antitumor activity in multiple other tumor types. An exciting component of immunotherapy is the durability of antitumor responses observed, with some patients achieving disease control for many years. Nevertheless, not all patients benefit, and efforts should thus now focus on improving the efficacy of immunotherapy through the use of combination approaches and predictive biomarkers of response and resistance. There are multiple potential rational combinations using an immunotherapy backbone, including existing treatments such as radiotherapy, chemotherapy or molecularly targeted agents, as well as other immunotherapeutics. The aim of such antitumor strategies will be to raise the tail on the survival curve by increasing the number of long term survivors, while managing any additive or synergistic toxicities that may arise with immunotherapy combinations. Rational trial designs based on a clear understanding of tumor biology and drug pharmacology remain paramount. This article reviews the biology underpinning immuno-oncology, discusses existing and novel immunotherapeutic combinations currently in development, the challenges of predictive biomarkers of response and resistance and the impact of immuno-oncology on early phase clinical trial design
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Trial endpoints for drug approval in oncology: Chemoprevention.
Beitz, J
2001-04-01
As with other drugs, new drug applications for marketing approval of chemopreventive drugs must include data from adequate and well-controlled clinical trials that demonstrate effectiveness and safety for the intended use. This article summarizes the regulatory requirements for traditional marketing approval, as well as for approval under the accelerated approval regulations. Unlike traditional approval, accelerated approval is based on a surrogate endpoint that is reasonably likely to predict clinical benefit. Discussions with the Food and Drug Administration (FDA) regarding the validity of trial endpoints that may serve as surrogates for clinical benefit for accelerated approval should take place as early as possible in drug development. Meetings with the FDA to discuss these issues may be requested throughout the clinical development of a new drug.
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Medicinal cannabis in oncology.
Engels, Frederike K; de Jong, Floris A; Mathijssen, Ron H J; Erkens, Joëlle A; Herings, Ron M; Verweij, Jaap
2007-12-01
In The Netherlands, since September 2003, a legal medicinal cannabis product, constituting the whole range of cannabinoids, is available for clinical research, drug development strategies, and on prescription for patients. To date, this policy, initiated by the Dutch Government, has not yet led to the desired outcome; the amount of initiated clinical research is less than expected and only a minority of patients resorts to the legal product. This review aims to discuss the background for the introduction of legal medicinal cannabis in The Netherlands, the past years of Dutch clinical experience in oncology practice, possible reasons underlying the current outcome, and future perspectives.
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Michigan Oncology Medical Home Demonstration Project: First-Year Results.
Kuntz, Gordon; Tozer, Jane; Snegosky, Jeff; Fox, John; Neumann, Kurt
2014-03-01
The Michigan Oncology Medical Home Demonstration Project (MOMHDP) is an innovative multipractice oncology medical home model, supported by payment reform. Sponsored by Priority Health, Physician Resource Management, and ION Solutions, MOMHDP includes four oncology practices and 29 physicians. Oncology practices used existing technologies, with MOMHDP providing evidence-based treatment guideline selection and compliance tracking, automated physician order entry, a patient portal, symptom management/standardized nurse triage, and advance care planning. To support changes in care and administrative models and to focus on quality, MOMHDP modifies provider payments. The program replaces the average sales price payment methodology with a drug acquisition reimbursement plus a care management fee, calculated to increase total drug reimbursement. Additionally, it reimburses for chemotherapy and treatment planning and advance care planning consultation. There is also a shared savings opportunity. MOMHDP will be enhanced in its second year to include a survivorship program, patient distress screening, imaging guidelines, and standardized patient satisfaction surveys. Priority Health patients receiving chemotherapy for a cancer diagnosis were recruited to the program. Results for this group were compared with a control group of patients from a prior period. In addition to the financial results, the project also accomplished the following: (1) adherence to practice-selected guidelines, (2) institution of advance care planning, (3) effective and standardized symptom management; and (4) payment reform. We have identified a number of critical success factors: strong payer/provider collaboration built on trust through transparent use and cost data; timing of clinical standardization must come from the practices, so they can effectively absorb new approaches; having comprehensive, written program documentation and consistently applied training facilitate practice understanding
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Content analysis of oncology-related pharmaceutical advertising in a peer-reviewed medical journal.
Directory of Open Access Journals (Sweden)
Kan Yonemori
Full Text Available BACKGROUND: The oncology market represents one of the largest pharmaceutical markets in any medical field, and printed advertising in medical journals is an important channel by which pharmaceutical companies communicate with healthcare professionals. The aim of the present study was to analyze the volume and content of and trends and changes in oncology-related advertising intended for healthcare professionals in a peer-reviewed medical journal. Information that could be included in advertisements to promote drug development and improve treatment strategies for cancer patients is discussed on the basis of the results of the analysis. METHODS/PRINCIPAL FINDINGS: Overall, 6,720 advertisements covering 13,039 pages in a leading oncology medical journal published (by the American Society of Clinical Oncology between January 2005 and December 2009 were analyzed. The advertisements targeting pharmaceuticals and clinical trials, in particular, were reviewed. A total of 6,720 advertisements covering 13,039 pages were included in the analysis. For the years 2005-2009, the percentages of total journal pages dedicated to advertising were 24.0%, 45.7%, 49.8%, 46.8%, and 49.8%, respectively. Package insert information and efficacy and safety explanations appeared in more than 80% of advertisements intended for pharmaceutical promotion. From 2005 to 2009, the overall quantity of drug advertisements decreased by approximately 13%, whereas advertisements calling for the enrollment of patients into registration trials increased by approximately 11%. CONCLUSION/SIGNIFICANCE: Throughout the study period, oncology-related pharmaceutical advertisements occupied a considerable number of pages relative to other journal content. The proportion of advertisements on ongoing clinical trials increased progressively throughout the study period.
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76 FR 1181 - Oncologic Drugs Advisory Committee; Notice of Meeting
2011-01-07
... or rectum) in patients for whom chemotherapy using irinotecan alone is ineffective or less effective... least two prior chemotherapy regimens; (4) NDA 21-877, tradename ARRANON (nelarabine) Injection, application submitted by GlaxoSmithKline, indicated for the treatment of patients with types of leukemia or...
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The Future of Gero-Oncology Nursing.
Kagan, Sarah H
2016-02-01
To project the future of gero-oncology nursing as a distinct specialty, framed between analysis of current challenges and explication of prospective solutions. Peer-reviewed literature, policy directives, web-based resources, and author expertise. Oncology nursing faces several challenges in meeting the needs of older people living with cancer. Realigning cancer nursing education, practice, and research to match demographic and epidemiological realities mandates redesign. Viewing geriatric oncology as an optional sub-specialty limits oncology nursing, where older people represent the majority of oncology patients and cancer survivors. The future of gero-oncology nursing lies in transforming oncology nursing itself. Specific goals to achieve transformation of oncology nursing into gero-oncology nursing include assuring integrated foundational aging and cancer content across entry-level nursing curricula; assuring a gero-competent oncology nursing workforce with integrated continuing education; developing gero-oncology nurse specialists in advanced practice roles; and cultivating nurse leadership in geriatric oncology program development and administration along with expanding the scope and sophistication of gero-oncology nursing science. Copyright © 2015 Elsevier Inc. All rights reserved.
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International Nuclear Information System (INIS)
1998-01-01
This paper collects some scientific research works on nuclear medicine developed in Ecuador. The main topics are: Brain metastases, computed tomography assessment; Therapeutic challenge in brain metastases, chemotherapy, surgery or radiotherapy; Neurocysticercosis and oncogenesis; Neurologic complications of radiation and chemotherapy; Cerebral perfusion gammagraphy in neurology and neurosurgery; Neuro- oncologic surgical patient anesthesic management; Pain management in neuro- oncology; Treatment of metastatic lesions of the spine, surgically decompression vs radiation therapy alone; Neuroimagining in spinal metastases
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75 FR 43156 - Federal Advisory Committee; Missile Defense Advisory Committee
2010-07-23
... DEPARTMENT OF DEFENSE Office of the Secretary Federal Advisory Committee; Missile Defense Advisory Committee AGENCY: Missile Defense Agency (MDA), DoD. ACTION: Notice of closed meeting. SUMMARY: Under the... Defense announces that the Missile Defense Advisory Committee will meet on August 4 and 5, 2010, in...
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HemOnc.org: A Collaborative Online Knowledge Platform for Oncology Professionals.
Warner, Jeremy L; Cowan, Andrew J; Hall, Aric C; Yang, Peter C
2015-05-01
Cancer care involves extensive knowledge about numerous chemotherapy drugs and chemotherapy regimens. This information is constantly evolving, and there has been no freely available, comprehensive, centralized repository of chemotherapy information to date. We created an online, freely accessible, ad-free, collaborative wiki of chemotherapy information entitled HemOnc.org to address the unmet need for a central repository of this information. This Web site was developed with wiki development software and is hosted on a cloud platform. Chemotherapy drug and regimen information (including regimen variants), as well as other information of interest to hematology/oncology professionals, is housed on the site in a fully referenced and standardized format. Accredited users are allowed to freely contribute information to the site. From its inception in November 2011, HemOnc.org has grown rapidly and most recently has detailed information on 383 drugs and 1,298 distinct chemotherapy regimens (not counting variants) in 92 disease subtypes. There are regularly more than 2,000 visitors per week from the United States and international locations. A user evaluation demonstrated that users find the site useful, usable, and recommendable. HemOnc.org is now the largest free source of chemotherapy drug and regimen information and is widely used. Future enhancements, including more metadata about drugs and increasingly detailed efficacy and toxicity information, will continue to improve the value of the resource. Copyright © 2015 by American Society of Clinical Oncology.
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Drug Interactions in Childhood Cancer
Haidar, Cyrine; Jeha, Sima
2016-01-01
Children with cancer are increasingly benefiting from novel therapeutic strategies and advances in supportive care, as reflected in improvements in both their survival and quality of life. However, the continuous emergence of new oncology drugs and supportive care agents has also increased the possibility of deleterious drug interactions and healthcare providers need to practice extreme caution when combining medications. In this review, we discuss the most common interactions of chemotherapeutic agents with supportive care drugs such as anticonvulsants, antiemetics, uric acid–lowering agents, acid suppressants, antimicrobials, and pain management medications in pediatric oncology patients. As chemotherapy agents interact not only with medications but also with foods and herbal supplements that patients receive during the course of their treatment, we also briefly review such interactions and provide recommendations to avoid unwanted and potentially fatal interactions in children with cancer. PMID:20869315
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2011-03-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA-2011-N-0002] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Microbiology...
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Psychosocial Issues in Pediatric Oncology
Marcus, Joel
2012-01-01
Psychosocial oncology, a relatively new discipline, is a multidisciplinary application of the behavioral and social sciences, and pediatric psychosocial oncology is an emerging subspecialty within the domain of psychosocial oncology. This review presents a brief overview of some of the major clinical issues surrounding pediatric psychosocial oncology. PMID:23049457
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Two approaches to bridging the knowledge-practice gap in oncology nursing.
Peek, Gloanna J
2015-01-01
The field of oncology nursing is continually changing. New drugs to aid in the fight against cancer are being developed, complementary therapies to ease symptoms are gaining prominence, and survivorship care is becoming a welcome yet challenging area of subspecialty. For oncology nurses to provide quality care and to develop improved care delivery systems, they must not only have access to the most current knowledge in the field, but also be equipped with the skills necessary to integrate that knowledge into practice for the benefit of patients and families (LoBiondo-Wood et al., 2014). The importance of nursing research and its relationship to the practice of oncology nursing cannot be minimized (Moore & Badger, 2014). Oncology nurse researchers advance knowledge and, consequently, improve the quality of care for patients with cancer and their families. For example, the Oncology Nursing Society (ONS) regularly surveys its membership to identify key areas of research focus that then guide the work of nurse investigators (LoBiondo-Wood et al., 2014; ONS Research Agenda Team, 2009). Unfortunately, the shortage of nurse scientists, particularly in oncology nursing, continues to increase as senior doctoral faculty reach retirement age and doctoral education program development remains stagnant (Glasgow & Dreher, 2010; LoBiondo-Wood et al., 2014). This shortage has and will continue to lead to gaps in the generation and implementation of new knowledge, negatively affecting the quality of patient care. As a result, an urgent need exists for innovative and quality doctoral educational programs to develop nurse scientists (Moore & Badger, 2014).
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78 FR 64956 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting
2013-10-30
... treatment of metabolic disorders associated with lipodystrophy, including diabetes mellitus and/or... than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a... 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee...
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Enzmann, Harald; Broich, Karl
2013-01-01
For innovative oncological medicines the centralised procedure at the European Medicines Agency is mandatory for a marketing authorisation application for the European Union. As with other medical drugs, the marketing authorisation decision is based on the assessment of its efficacy, safety and pharmaceutical quality but does not consider price or reimbursement. More sophisticated diagnostic methods drive an increasing stratification of cancer into a multitude of different diseases. Regardless of their different pathogenesis and therapeutic options the most relevant clinical endpoints remain cure, overall survival and progression free survival. These endpoints include both efficacy and safety, as patient survival reflects the sum of the beneficial anti-tumour effects (increasing survival) AND the adverse effects (decreasing survival). The benefit of an anticancer medicine should be evident from both overall survival and progression free survival (e.g. used as primary and secondary endpoints). Mature data on overall survival may not be needed for marketing authorisation if a clear increase in progression free survival convincingly predicts a beneficial effect on overall survival. In these exceptional cases treatment of patients with an obviously beneficial medicine must not be delayed - possibly for years - until the exact size of the benefit has been established. The continued stratification of the disease cancer results in a lower prevalence for each of the newly distinguished disease entities and an ever increasing number of orphan designations for medicines for rare diseases. Incentives for the development of orphan medicines include market exclusivity for up to ten years. In specific circumstances, however, the orphan legislation may restrict the authorisation and marketing of competing generic products even beyond these ten years. Conditional approval and approval under exceptional circumstances may accelerate patients' access to a new medicine. Both postulate
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Morgan, Gilberto; Aftimos, Philippe; Awada, Ahmad
2016-09-01
Precision oncology has been a strategy of prevention, screening, and treatment. Although much has been invested, have the results fallen so far short of the promise? The advancement of technology and research has opened new doors, yet a variety of pitfalls are present. This review presents the successes, failures, and opportunities of precision oncology in the current landscape. The use of targeted gene sequencing and the overwhelming results of superresponders have generated much excitement and support for precision oncology from the medical community. Despite notable successes, many challenges still pave the way of precision oncology: intratumoral heterogeneity, the need for serial biopsies, availability of treatments, target prioritization, ethical issues with germline incidental findings, medical education, clinical trial design, and costs. Precision oncology shows much potential through the use of next-generation sequencing and molecular advances, but does this potential warrant the investment? There are many obstacles on the way of this technology that should make us question if the investment (both monetary and man-hours) will live up to the promise. The review aims to not criticize this technology, but to give a realistic view of where we are, especially regarding cancer treatment and prevention.
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2011-03-18
... Alcohol Abuse and Alcoholism; National Institute on Drug Abuse; Notice of Meeting Pursuant to section 10(a... meeting of the National Advisory Council on Alcohol Abuse and Alcoholism and the National Advisory Council on Drug Abuse. The meeting will be open to the public, with attendance limited to space available...
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Future Research in Psycho-Oncology.
Goerling, Ute; Mehnert, Anja
2018-01-01
Since the mid-1970s psycho-oncology and psycho-oncological research have been systematically developed in many industrialized countries and have produced nationally and internationally accepted guidelines. In this article developments and challenges are presented and discussed. From the perspective of various oncological treatment options, different needs for further psycho-oncological research are considered.
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Full Text Available ... Meetings & Events Media Guide About NIDA Director's Page Organization Legislative Activities Advisory Boards & Groups Working at NIDA Donating to ... 2005 –Ongoing Behaviors associated with drug misuse are among the main ...
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Oncology pharma costs to exceed $150 billion by 2020.
2016-10-01
Worldwide costs of oncology drugs will rise above $150 billion by 2020, according to a report by the IMS Institute for Healthcare Informatics. Many factors are in play, according to IMS, including the new wave of expensive immunotherapies. Pembrolizumab (Keytruda), priced at $150,000 per year per patient, and nivolumab (Opdivo), priced at $165,000, may be harbingers of the market for cancer immunotherapies.
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Career opportunities in oncology.
Farrow, L
Oncology nursing offers nurses a wide range of opportunities. Nurses need a wide range of skills in order to care for patients who may have acute oncological illnesses or require palliative care. The nature of the nurse/patient relationship can be intense. Nurses generally find this enhances job satisfaction. The pressures exerted on nurses working in oncology can be immense. Oncology nursing is rewarding but very demanding and therefore the nurse has to be resourceful. Early career planning is advisable to take advantage of the opportunities that are currently available.
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... BTTC are experts in their respective fields. Neuro-Oncology Clinical Fellowship This is a joint program with ... can increase survival rates. Learn more... The Neuro-Oncology Branch welcomes Dr. Mark Gilbert as new Branch ...
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Precision medicine in oncology: New practice models and roles for oncology pharmacists.
Walko, Christine; Kiel, Patrick J; Kolesar, Jill
2016-12-01
Three different precision medicine practice models developed by oncology pharmacists are described, including strategies for implementation and recommendations for educating the next generation of oncology pharmacy practitioners. Oncology is unique in that somatic mutations can both drive the development of a tumor and serve as a therapeutic target for treating the cancer. Precision medicine practice models are a forum through which interprofessional teams, including pharmacists, discuss tumor somatic mutations to guide patient-specific treatment. The University of Wisconsin, Indiana University, and Moffit Cancer Center have implemented precision medicine practice models developed and led by oncology pharmacists. Different practice models, including a clinic, a clinical consultation service, and a molecular tumor board (MTB), were adopted to enhance integration into health systems and payment structures. Although the practice models vary, commonalities of three models include leadership by the clinical pharmacist, specific therapeutic recommendations, procurement of medications for off-label use, and a research component. These three practice models function as interprofessional training sites for pharmacy and medical students and residents, providing an important training resource at these institutions. Key implementation strategies include interprofessional involvement, institutional support, integration into clinical workflow, and selection of model by payer mix. MTBs are a pathway for clinical implementation of genomic medicine in oncology and are an emerging practice model for oncology pharmacists. Because pharmacists must be prepared to participate fully in contemporary practice, oncology pharmacy residents must be trained in genomic oncology, schools of pharmacy should expand precision medicine and genomics education, and opportunities for continuing education in precision medicine should be made available to practicing pharmacists. Copyright © 2016 by the
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Clinical and Radiation Oncology. Vol. 1
International Nuclear Information System (INIS)
Jurga, L.; Adam, Z.; Autrata, R.
2010-01-01
The work is two-volume set and has 1,658 pages. It is divided into 5 sections: I. Principles Clinical and radiation oncology. II. Hematological Malignant tumors. III. Solid tumors. IV. Treatment options metastatic Disease. V. Clinical practice in oncology. First volume contains following sections a chapters: Section I: Principles of clinical and radiation oncology, it contains following chapters: (1) The history of clinical/experimental and radiation oncology in the Czech Republic; (2) The history of clinical/experimental and radiation oncology in the Slovak Republic - development and development of oncology in Slovakia; (3) Clinical and radiation oncology as part of evidence-based medicine; (4) Molecular biology; (5) Tumor Disease; (6) Epidemiology and prevention of malignant tumors; (7) Diagnosis, staging, stratification and monitoring of patients in oncology; (8) Imaging methods in oncology; (9) Principles of surgical treatment of cancer diseases; (10) Symptomatology and signaling of malignant tumors - systemic, paraneoplastic and paraendocrine manifestations of tumor diseases; (11) Principles of radiation oncology; (12 Modeling radiobiological effects of radiotherapy; (13) Principles of anticancer chemotherapy; (14) Hormonal manipulation in the treatment of tumors; (15) Principles of biological and targeted treatment of solid tumors; (16) Method of multimodal therapy of malignant tumors; (17) Evaluation of treatment response, performance evaluation criteria (RECIST); (18) Adverse effects of cancer chemotherapy and the principles of their prevention and treatment; (19) Biological principles of hematopoietic stem cell transplantation; (20) Design, analysis and ethical aspects of clinical studies in oncology; (21) Fundamentals of biostatistics for oncologists; (22) Information infrastructure for clinical and radiological oncology based on evidence; (23) Pharmacoeconomic aspects in oncology; (24) Respecting patient preferences when deciding on the strategy and
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Potential non-oncological applications of histone deacetylase inhibitors.
Ververis, Katherine; Karagiannis, Tom C
2011-01-01
Histone deacetylase inhibitors have emerged as a new class of anticancer therapeutic drugs. Their clinical utility in oncology stems from their intrinsic cytotoxic properties and combinatorial effects with other conventional cancer therapies. To date, the histone deacetylase inhibitors suberoylanilide hydroxamic acid (Vorinostat, Zolinza®) and depsipeptide (Romidepsin, Istodax®) have been approved by the US Food and Drug Administration for the treatment of refractory cutaneous T-cell lymphoma. Further, there are currently over 100 clinical trials involving the use of histone deacetylase inhibitors in a wide range of solid and hematological malignancies. The therapeutic potential of histone deacetylase inhibitors has also been investigated for numerous other diseases. For example, the cytotoxic properties of histone deacetylase inhibitors are currently being harnessed as a potential treatment for malaria, whereas the efficacy of these compounds for HIV relies on de-silencing latent virus. The anti-inflammatory properties of histone deacetylase inhibitors are the predominant mechanisms for other diseases, such as hepatitis, systemic lupus erythematosus and a wide range of neurodegenerative conditions. Additionally, histone deacetylase inhibitors have been shown to be efficacious in animal models of cardiac hypertrophy and asthma. Broad-spectrum histone deacetylase inhibitors are clinically available and have been used almost exclusively in preclinical systems to date. However, it is emerging that class- or isoform-specific compounds, which are becoming more readily available, may be more efficacious particularly for non-oncological applications. The aim of this review is to provide an overview of the effects and clinical potential of histone deacetylase inhibitors in various diseases. Apart from applications in oncology, the discussion is focused on the potential efficacy of histone deacetylase inhibitors for the treatment of neurodegenerative diseases, cardiac
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75 FR 36373 - Federal Advisory Committee; Advisory Council on Dependents' Education
2010-06-25
..., the Department of Defense announces that the Advisory Council on Dependents' Education will meet on... response to the stated agenda of the planned meeting of the Advisory Council on Dependents' Education. All... membership for their consideration. For the next meeting of the Advisory Council on Dependents' Education, Dr...
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75 FR 22146 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting
2010-04-27
... of the treatment of hypoactive sexual desire disorder in premenopausal women. FDA intends to make... public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public... least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory...
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21 CFR 14.22 - Meetings of an advisory committee.
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Meetings of an advisory committee. 14.22 Section... of, and with an agenda approved by, the designated Federal employee or alternate. No meeting may be held in the absence of the designated Federal employee. (1) If any matter is added to the agenda after...
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Diagnosis and treatment of pancreatic cancer. Oncology overview
International Nuclear Information System (INIS)
1982-09-01
Oncology Overviews are a service of the International Cancer Research Data Bank (ICRDB) Program of the National Cancer Institute, intended to facilitate and promote the exchange of information between cancer scientists by keeping them aware of literature related to their research being published by other laboratories throughout the world. Each Oncology Overview represents a survey of the literature associated with a selected area of cancer research. It contains abstracts of articles which have been selected and organized by researchers associated with the field. Contents: Radiological diagnosis of pancreatic cancer; Biopsy and cytology in the diagnosis of pancreatic cancer; Pathology and morphology of pancreatic cancer; Staging and prognosis of pancreatic cancer; Biological and immunological markers in the diagnosis of pancreatic cancer; Surgical treatment of pancreatic cancer; Drug therapy of pancreatic cancer; Radiation therapy of pancreatic cancer; Selected studies on the epidemiology of pancreatic cancer; Clinical correlates and syndromes associated with pancreatic neoplasia
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Value Frameworks in Oncology: Comparative Analysis and Implications to the Pharmaceutical Industry.
Slomiany, Mark; Madhavan, Priya; Kuehn, Michael; Richardson, Sasha
2017-07-01
As the cost of oncology care continues to rise, composite value models that variably capture the diverse concerns of patients, physicians, payers, policymakers, and the pharmaceutical industry have begun to take shape. To review the capabilities and limitations of 5 of the most notable value frameworks in oncology that have emerged in recent years and to compare their relative value and application among the intended stakeholders. We compared the methodology of the American Society of Clinical Oncology (ASCO) Value Framework (version 2.0), the National Comprehensive Cancer Network Evidence Blocks, Memorial Sloan Kettering Cancer Center DrugAbacus, the Institute for Clinical and Economic Review Value Assessment Framework, and the European Society for Medical Oncology Magnitude of Clinical Benefit Scale, using a side-by-side comparative approach in terms of the input, scoring methodology, and output of each framework. In addition, we gleaned stakeholder insights about these frameworks and their potential real-world applications through dialogues with physicians and payers, as well as through secondary research and an aggregate analysis of previously published survey results. The analysis identified several framework-specific themes in their respective focus on clinical trial elements, breadth of evidence, evidence weighting, scoring methodology, and value to stakeholders. Our dialogues with physicians and our aggregate analysis of previous surveys revealed a varying level of awareness of, and use of, each of the value frameworks in clinical practice. For example, although the ASCO Value Framework appears nascent in clinical practice, physicians believe that the frameworks will be more useful in practice in the future as they become more established and as their outputs are more widely accepted. Along with patients and payers, who bear the burden of treatment costs, physicians and policymakers have waded into the discussion of defining value in oncology care, as well
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The Radiation Therapy Oncology in the context of oncological practice
International Nuclear Information System (INIS)
Kasdorf, P.
2010-01-01
This work is about the radiation therapy oncology in the context of oncological practice. The radiotherapy is a speciality within medicine that involves the generation, application and dissemination of knowledge about the biology, causes, prevention and treatment of the cancer and other pathologies by ionising radiation
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75 FR 22757 - Federal Advisory Committee; Army Education Advisory Committee; Charter Renewal
2010-04-30
..., school curriculums, educational philosophy and objectives, program effectiveness, facilities, staff and... DEPARTMENT OF DEFENSE Office of the Secretary Federal Advisory Committee; Army Education Advisory... Defense gives notice that it is renewing the charter for the Army Education Advisory Committee (hereafter...
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Basch, Ethan; Geoghegan, Cindy; Coons, Stephen Joel; Gnanasakthy, Ari; Slagle, Ashley F; Papadopoulos, Elektra J; Kluetz, Paul G
2015-06-01
Data reported directly by patients about how they feel and function are rarely included in oncology drug labeling in the United States, in contrast to Europe and to nononcology labeling in the United States, where this practice is more common. Multiple barriers exist, including challenges unique to oncology trials, and industry's concerns regarding cost, logistical complexities, and the Food and Drug Administration's (FDA's) rigorous application of its 2009 guidance on the use of patient-reported outcome (PRO) measures. A panel consisting of representatives of industry, FDA, the PRO Consortium, clinicians, and patients was assembled at a 2014 workshop cosponsored by FDA to identify practical recommendations for overcoming these barriers. Key recommendations included increasing proactive encouragement by FDA to clinical trial sponsors for including PROs in drug development programs; provision of comprehensive PRO plans by sponsors to FDA early in drug development; promotion of an oncology-specific PRO research agenda; development of an approach to existing ("legacy") PRO measures, when appropriate (focused initially on symptoms and functional status); and increased FDA and industry training in PRO methodology. FDA has begun implementing several of these recommendations.
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Quality Indicators in Radiation Oncology
Energy Technology Data Exchange (ETDEWEB)
Albert, Jeffrey M. [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Das, Prajnan, E-mail: prajdas@mdanderson.org [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States)
2013-03-15
Oncologic specialty societies and multidisciplinary collaborative groups have dedicated considerable effort to developing evidence-based quality indicators (QIs) to facilitate quality improvement, accreditation, benchmarking, reimbursement, maintenance of certification, and regulatory reporting. In particular, the field of radiation oncology has a long history of organized quality assessment efforts and continues to work toward developing consensus quality standards in the face of continually evolving technologies and standards of care. This report provides a comprehensive review of the current state of quality assessment in radiation oncology. Specifically, this report highlights implications of the healthcare quality movement for radiation oncology and reviews existing efforts to define and measure quality in the field, with focus on dimensions of quality specific to radiation oncology within the “big picture” of oncologic quality assessment efforts.
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Quality Indicators in Radiation Oncology
International Nuclear Information System (INIS)
Albert, Jeffrey M.; Das, Prajnan
2013-01-01
Oncologic specialty societies and multidisciplinary collaborative groups have dedicated considerable effort to developing evidence-based quality indicators (QIs) to facilitate quality improvement, accreditation, benchmarking, reimbursement, maintenance of certification, and regulatory reporting. In particular, the field of radiation oncology has a long history of organized quality assessment efforts and continues to work toward developing consensus quality standards in the face of continually evolving technologies and standards of care. This report provides a comprehensive review of the current state of quality assessment in radiation oncology. Specifically, this report highlights implications of the healthcare quality movement for radiation oncology and reviews existing efforts to define and measure quality in the field, with focus on dimensions of quality specific to radiation oncology within the “big picture” of oncologic quality assessment efforts
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75 FR 51985 - Federal Advisory Committee; Advisory Council on Dependents' Education (ACDE)
2010-08-24
... Advisory Council on Dependents' Education (ACDE) scheduled for September 8, 2010, is cancelled. The meeting... submit written statements to the Advisory Council on Dependents' Education about its mission and... planned meeting of the Advisory Council on Dependents' Education. All written statements shall be...
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Analgesic stairway in the treatment of oncological pain
Directory of Open Access Journals (Sweden)
Sarah María Regueira Betancourt
2015-10-01
Full Text Available Pain represents the main symptom in an important group of patients who are in active treatment for cancer and in sick people in a very advanced stage. The objective of this article is to review the basic pharmacology of the nonsteroidal antiinflammatory drugs, weak opioids, bigger opioids, as well as the different special pharmacological and non- pharmacological techniques that constitute the analgesic stairway in the management of patients who are suffering from oncological pain.
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Oncology In Vivo Data Integration for Hypothesis Generation
Directory of Open Access Journals (Sweden)
Wei Jia
2012-06-01
Full Text Available AstraZeneca’s Oncology in vivo data integration platform brings multidimensional data from animal model efficacy, pharmacokinetic and pharmacodynamic data to animal model profiling data and public in vivo studies. Using this platform, scientists can cluster model efficacy and model profiling data together, quickly identify responder profiles and correlate molecular characteristics to pharmacological response. Through meta-analysis, scientists can compare pharmacology between single and combination treatments, between different drug scheduling and administration routes.
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PRIMARY OPEN-ANGLE GLAUCOMA IN ONCOLOGIC PATIENTS
Directory of Open Access Journals (Sweden)
A. A. Ryabtseva
2015-01-01
Full Text Available Background: Glaucoma-induced visual impairment negatively influences quality of life of oncologic patients. Yet, tumor in itself and methods of its treatment may promote glaucoma progression. Aim: To study characteristics and course of primary open-angle glaucoma in oncologic patients. Materials and methods: We analyzed case reports of 19 oncologic patients after primary open-angle glaucoma-related sinus trabeculectomy (34 eyes and laser cyclopexy (1 eye. Diagnosed malignancies included colorectal cancer in 5 patients, uterine body and cervical cancer in 4 patients, chronic lymphocytic leukemia in 1 patient, renal cell carcinoma in 1 patient, adrenal cancer in 1 patient, prostatic cancer in 1 patient, breast cancer in 1 patient, vulvar cancer in 1 patient, tongue root cancer in 1 patient. Antiglaucomatous surgery was accomplished during the first 5 years from the diagnosis of tumor in 14 patients. In 9 patients, chemotherapy or hormone therapy was continued by the time of surgery. Follow-up of the patients was undertaken in 4–12 months after the antiglaucomatous operation; it included routine ophthalmological examination and dry eye syndrome functional tests. Results: Duration of postoperative period was 4 months or more. All patients had uveitis postoperatively. During late postoperative period, choroidal detachment was diagnosed in 4 patients. Bleb scarring was found in 2 patients. All patients received hypotensive treatment postoperatively including selective and non-selective beta-adrenergic blockers. Conjunctival and corneal xerosis was observed in all patients. Conclusion: In oncologic patients undergoing antiglaucomatous surgery, long-term (4 months or more postoperative anti-inflammatory therapy is needed along with monthly ophthalmological follow-up during the first year after the operation. In patients with ongoing cytostatic drug treatment, artificial tear should be administrated.
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[Genetic therapy in oncology: ethical aspects].
Bucci, L M; Fazio, V M
2001-01-01
The more advanced oncologic therapies are directing toward new frontiers, on account of the remarkable undesirable effects of chemio- and radio-therapies. This new therapeutic experiences are of type biological (vaccines), or genic (substitution again genes with shutters meaning-tumoral). This therapies involve, to be effected, some ethical shrewdnesses: choice of the patient, the engineering modality of the genes, the transfer of the genes in cells of the exclusively somatic line, the elimination of the pathogenic risk of the vector virus, the obligatory use of sterile rooms, the attention to the administration of the drug, a legal issue of the judgment of notoriety.
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E-learning programs in oncology
DEFF Research Database (Denmark)
Degerfält, Jan; Sjöstedt, Staffan; Fransson, Per
2017-01-01
BACKGROUND: E-learning is an established concept in oncological education and training. However, there seems to be a scarcity of long-term assessments of E-learning programs in oncology vis-á-vis their structural management and didactic value. This study presents descriptive, nationwide data from...... 2005 to 2014. E-learning oncology programs in chemotherapy, general oncology, pain management, palliative care, psycho-social-oncology, and radiotherapy, were reviewed from our databases. Questionnaires of self-perceived didactic value of the programs were examined 2008-2014. RESULTS: The total number.......6% (MDs: 64.9%; RNs: 66.8%; SHCAs: 77.7%) and as good by 30.6% (MDs: 34.5%; RNs: 32.4%; SHCAs: 21.5%) of the responders. CONCLUSIONS: This descriptive study, performed in a lengthy timeframe, presents high-volume data from multi-professional, oncological E-learning programs. While the E-learning paradigm...
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Guidelines on oncologic imaging
International Nuclear Information System (INIS)
1989-01-01
The present issue of European Journal of Radiology is devoted to guidelines on oncologic imaging. 9 experts on imaging in suspected or evident oncologic disease have compiled a broad survey on strategies as well as techniques on oncologic imaging. The group gives advice for detecting tumours at specific tumour sites and use modern literature to emphasize their recommendations. All recommendations are short, comprehensive and authoritative. (orig./MG)
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Kline, Ronald M; Muldoon, L Daniel; Schumacher, Heidi K; Strawbridge, Larisa M; York, Andrew W; Mortimer, Laura K; Falb, Alison F; Cox, Katherine J; Bazell, Carol; Lukens, Ellen W; Kapp, Mary C; Rajkumar, Rahul; Bassano, Amy; Conway, Patrick H
2017-07-01
The Centers for Medicare & Medicaid Services developed the Oncology Care Model as an episode-based payment model to encourage participating practitioners to provide higher-quality, better-coordinated care at a lower cost to the nearly three-quarter million fee-for-service Medicare beneficiaries with cancer who receive chemotherapy each year. Episode payment models can be complex. They combine into a single benchmark price all payments for services during an episode of illness, many of which may be delivered at different times by different providers in different locations. Policy and technical decisions include the definition of the episode, including its initiation, duration, and included services; the identification of beneficiaries included in the model; and beneficiary attribution to practitioners with overall responsibility for managing their care. In addition, the calculation and risk adjustment of benchmark episode prices for the bundle of services must reflect geographic cost variations and diverse patient populations, including varying disease subtypes, medical comorbidities, changes in standards of care over time, the adoption of expensive new drugs (especially in oncology), as well as diverse practice patterns. Other steps include timely monitoring and intervention as needed to avoid shifting the attribution of beneficiaries on the basis of their expected episode expenditures as well as to ensure the provision of necessary medical services and the development of a meaningful link to quality measurement and improvement through the episode-based payment methodology. The complex and diverse nature of oncology business relationships and the specific rules and requirements of Medicare payment systems for different types of providers intensify these issues. The Centers for Medicare & Medicaid Services believes that by sharing its approach to addressing these decisions and challenges, it may facilitate greater understanding of the model within the oncology
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Antineoplastic drugs: Occupational exposure and health risks
Fransman, W.
2006-01-01
Antineoplastic drugs are pharmaceuticals commonly used to treat cancer (and some non-neoplastic diseases), which are generally referred to as 'chemotherapy'. Oncology nurses are exposed to these drugs via the skin of hands during daily nursing activities, even when protective gloves are being used.
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2011-05-23
... Management, for the purpose of identifying leading business practices that have the potential to improve...'s Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting AGENCY: Office...: The President's Management Advisory Board, a Federal Advisory Committee established in accordance with...
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Babiker, Hani M; McBride, Ali; Newton, Michael; Boehmer, Leigh M; Drucker, Adrienne Goeller; Gowan, Mollie; Cassagnol, Manouchkathe; Camenisch, Todd D; Anwer, Faiz; Hollands, James M
2018-06-01
Cardiotoxic effects of chemotherapy and targeted drugs are ubiquitous and challenging in the field of oncology therapeutics. The broad spectrum of toxicities ranging from ischemic, hypertensive, cardiomyopathic, and arrhythmic complications can present as a significant challenge for clinicians treating cancer patients. If early diagnosis and intervention of cardiotoxic complications is missed, this can lead to delay or abrogation of planned treatment, which can potentially culminate to significant morbidity due to not only the cardiotoxic complications but also the progression of cancer. Hence, full knowledge of cardiovascular complications of chemotherapeutic agents, essential diagnostics tests to order, and appropriate management is paramount to oncologist, oncology pharmacists, and scientific clinical investigators. The aforementioned is particularly true in the current oncology era of plenteous early clinical trials studying several pathway/molecular-targeting agents with an increased cardiotoxic potential and the rapid expedited approval of those drugs by the FDA. Herein, we present a review discussing cardiotoxic effects of drugs and guidelines for management of the toxicities to assist the medical field in general managing patients with cancer. Copyright © 2018 Elsevier B.V. All rights reserved.
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Global curriculum in surgical oncology.
Are, C; Berman, R S; Wyld, L; Cummings, C; Lecoq, C; Audisio, R A
2016-06-01
The significant global variations in surgical oncology training paradigms can have a detrimental effect on tackling the rising global cancer burden. While some variations in training are essential to account for the differences in types of cancer and biology, the fundamental principles of providing care to a cancer patient remain the same. The development of a global curriculum in surgical oncology with incorporated essential standards could be very useful in building an adequately trained surgical oncology workforce, which in turn could help in tackling the rising global cancer burden. The leaders of the Society of Surgical Oncology and European Society of Surgical Oncology convened a global curriculum committee to develop a global curriculum in surgical oncology. A global curriculum in surgical oncology was developed to incorporate the required domains considered to be essential in training a surgical oncologist. The curriculum was constructed in a modular fashion to permit flexibility to suit the needs of the different regions of the world. Similarly, recognizing the various sociocultural, financial and cultural influences across the world, the proposed curriculum is aspirational and not mandatory in intent. A global curriculum was developed which may be considered as a foundational scaffolding for training surgical oncologists worldwide. It is envisioned that this initial global curriculum will provide a flexible and modular scaffolding that can be tailored by individual countries or regions to train surgical oncologists in a way that is appropriate for practice in their local environment. Copyright © 2016 Society of Surgical Oncology, European Society of Surgical Oncology. Published by Elsevier Ltd.. All rights reserved.
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Neuss, Michael N; Gilmore, Terry R; Belderson, Kristin M; Billett, Amy L; Conti-Kalchik, Tara; Harvey, Brittany E; Hendricks, Carolyn; LeFebvre, Kristine B; Mangu, Pamela B; McNiff, Kristen; Olsen, MiKaela; Schulmeister, Lisa; Von Gehr, Ann; Polovich, Martha
2016-12-01
Purpose To update the ASCO/Oncology Nursing Society (ONS) Chemotherapy Administration Safety Standards and to highlight standards for pediatric oncology. Methods The ASCO/ONS Chemotherapy Administration Safety Standards were first published in 2009 and updated in 2011 to include inpatient settings. A subsequent 2013 revision expanded the standards to include the safe administration and management of oral chemotherapy. A joint ASCO/ONS workshop with stakeholder participation, including that of the Association of Pediatric Hematology Oncology Nurses and American Society of Pediatric Hematology/Oncology, was held on May 12, 2015, to review the 2013 standards. An extensive literature search was subsequently conducted, and public comments on the revised draft standards were solicited. Results The updated 2016 standards presented here include clarification and expansion of existing standards to include pediatric oncology and to introduce new standards: most notably, two-person verification of chemotherapy preparation processes, administration of vinca alkaloids via minibags in facilities in which intrathecal medications are administered, and labeling of medications dispensed from the health care setting to be taken by the patient at home. The standards were reordered and renumbered to align with the sequential processes of chemotherapy prescription, preparation, and administration. Several standards were separated into their respective components for clarity and to facilitate measurement of adherence to a standard. Conclusion As oncology practice has changed, so have chemotherapy administration safety standards. Advances in technology, cancer treatment, and education and training have prompted the need for periodic review and revision of the standards. Additional information is available at http://www.asco.org/chemo-standards .
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Perez, Raymond; Archdeacon, Patrick; Roach, Nancy; Goodwin, Robert; Jarow, Jonathan; Stuccio, Nina; Forrest, Annemarie
2017-01-01
Background/aims: The Food and Drug Administration’s final rule on investigational new drug application safety reporting, effective from 28 March 2011, clarified the reporting requirements for serious and unexpected suspected adverse reactions occurring in clinical trials. The Clinical Trials Transformation Initiative released recommendations in 2013 to assist implementation of the final rule; however, anecdotal reports and data from a Food and Drug Administration audit indicated that a majority of reports being submitted were still uninformative and did not result in actionable changes. Clinical Trials Transformation Initiative investigated remaining barriers and potential solutions to full implementation of the final rule by polling and interviewing investigators, clinical research staff, and sponsors. Methods: In an opinion-gathering effort, two discrete online surveys designed to assess challenges and motivations related to management of expedited (7- to 15-day) investigational new drug safety reporting processes in oncology trials were developed and distributed to two populations: investigators/clinical research staff and sponsors. Data were collected for approximately 1 year. Twenty-hour-long interviews were also conducted with Clinical Trials Transformation Initiative–nominated interview participants who were considered as having extensive knowledge of and experience with the topic. Interviewees included 13 principal investigators/study managers/research team members and 7 directors/vice presidents of pharmacovigilance operations from 5 large global pharmaceutical companies. Results: The investigative site’s responses indicate that too many individual reports are still being submitted, which are time-consuming to process and provide little value for patient safety assessments or for informing actionable changes. Fewer but higher quality reports would be more useful, and the investigator and staff would benefit from sponsors’“filtering” of
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Perez, Raymond; Archdeacon, Patrick; Roach, Nancy; Goodwin, Robert; Jarow, Jonathan; Stuccio, Nina; Forrest, Annemarie
2017-06-01
The Food and Drug Administration's final rule on investigational new drug application safety reporting, effective from 28 March 2011, clarified the reporting requirements for serious and unexpected suspected adverse reactions occurring in clinical trials. The Clinical Trials Transformation Initiative released recommendations in 2013 to assist implementation of the final rule; however, anecdotal reports and data from a Food and Drug Administration audit indicated that a majority of reports being submitted were still uninformative and did not result in actionable changes. Clinical Trials Transformation Initiative investigated remaining barriers and potential solutions to full implementation of the final rule by polling and interviewing investigators, clinical research staff, and sponsors. In an opinion-gathering effort, two discrete online surveys designed to assess challenges and motivations related to management of expedited (7- to 15-day) investigational new drug safety reporting processes in oncology trials were developed and distributed to two populations: investigators/clinical research staff and sponsors. Data were collected for approximately 1 year. Twenty-hour-long interviews were also conducted with Clinical Trials Transformation Initiative-nominated interview participants who were considered as having extensive knowledge of and experience with the topic. Interviewees included 13 principal investigators/study managers/research team members and 7 directors/vice presidents of pharmacovigilance operations from 5 large global pharmaceutical companies. The investigative site's responses indicate that too many individual reports are still being submitted, which are time-consuming to process and provide little value for patient safety assessments or for informing actionable changes. Fewer but higher quality reports would be more useful, and the investigator and staff would benefit from sponsors'"filtering" of reports and increased sponsor communication. Sponsors
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McDonald, Heather; Charles, Cathy; Elit, Laurie; Gafni, Amiram
2016-01-01
The pan-Canadian Oncology Drug Review (pCODR) makes recommendations to Canada's provinces and territories (except Quebec) to guide their cancer drug funding decisions. The objective of this paper is to explore, using an economic perspective and the pCODR as an example, the challenges associated with striving to simultaneously achieve the goals of maximizing health benefits with available resources and improving access to a more consistent standard of care across Canada. The first challenge concerns how to interpret the goals in order to determine how resources should be allocated to achieve each goal. The second challenge relates to whether, if pursued simultaneously, both goals can be achieved to the same extent that each goal could have been achieved alone with the same available resources. Regarding the first challenge, we illustrate that, due to a lack of definitional clarity, it is difficult to determine exactly how resources should be allocated in order to achieve the goal of improving access to a more consistent standard of care across Canada. Regarding the second challenge, we illustrate that choosing to strive for both of the pCODR goals simultaneously will likely be associated with tradeoffs in the extent to which one or both goals can be achieved (relative to what could have been achieved for each goal alone with the same available resources). We suggest that, if the pCODR and the provincial drug plan decision-makers it supports want to strive for both goals simultaneously, they must prioritize the goals and explicitly identify the tradeoffs associated with the prioritization. This will ensure that the consequences of striving to simultaneously achieve both goals are explicit, transparent, and predictable for provincial drug plan decision-makers, physicians, patients, caregivers, and society as a whole.
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Venkatakrishnan, K; Friberg, L E; Ouellet, D; Mettetal, J T; Stein, A; Trocóniz, I F; Bruno, R; Mehrotra, N; Gobburu, J; Mould, D R
2015-01-01
Despite advances in biomedical research that have deepened our understanding of cancer hallmarks, resulting in the discovery and development of targeted therapies, the success rates of oncology drug development remain low. Opportunities remain for objective dose selection informed by exposure-response understanding to optimize the benefit-risk balance of novel therapies for cancer patients. This review article discusses the principles and applications of modeling and simulation approaches across the lifecycle of development of oncology therapeutics. Illustrative examples are used to convey the value gained from integration of quantitative clinical pharmacology strategies from the preclinical-translational phase through confirmatory clinical evaluation of efficacy and safety. © 2014 American Society for Clinical Pharmacology and Therapeutics.
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Hernandez, J Javier; Pryszlak, Michael; Smith, Lindsay; Yanchus, Connor; Kurji, Naheed; Shahani, Vijay M; Molinski, Steven V
2017-01-01
The repositioning or "repurposing" of existing therapies for alternative disease indications is an attractive approach that can save significant investments of time and money during drug development. For cancer indications, the primary goal of repurposed therapies is on efficacy, with less restriction on safety due to the immediate need to treat this patient population. This report provides a high-level overview of how drug developers pursuing repurposed assets have previously navigated funding efforts, regulatory affairs, and intellectual property laws to commercialize these "new" medicines in oncology. This article provides insight into funding programs (e.g., government grants and philanthropic organizations) that academic and corporate initiatives can leverage to repurpose drugs for cancer. In addition, we highlight previous examples where secondary uses of existing, Food and Drug Administration- or European Medicines Agency-approved therapies have been predicted in silico and successfully validated in vitro and/or in vivo (i.e., animal models and human clinical trials) for certain oncology indications. Finally, we describe the strategies that the pharmaceutical industry has previously employed to navigate regulatory considerations and successfully commercialize their drug products. These factors must be carefully considered when repurposing existing drugs for cancer to best benefit patients and drug developers alike.
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Directory of Open Access Journals (Sweden)
J. Javier Hernandez
2017-11-01
Full Text Available The repositioning or “repurposing” of existing therapies for alternative disease indications is an attractive approach that can save significant investments of time and money during drug development. For cancer indications, the primary goal of repurposed therapies is on efficacy, with less restriction on safety due to the immediate need to treat this patient population. This report provides a high-level overview of how drug developers pursuing repurposed assets have previously navigated funding efforts, regulatory affairs, and intellectual property laws to commercialize these “new” medicines in oncology. This article provides insight into funding programs (e.g., government grants and philanthropic organizations that academic and corporate initiatives can leverage to repurpose drugs for cancer. In addition, we highlight previous examples where secondary uses of existing, Food and Drug Administration- or European Medicines Agency-approved therapies have been predicted in silico and successfully validated in vitro and/or in vivo (i.e., animal models and human clinical trials for certain oncology indications. Finally, we describe the strategies that the pharmaceutical industry has previously employed to navigate regulatory considerations and successfully commercialize their drug products. These factors must be carefully considered when repurposing existing drugs for cancer to best benefit patients and drug developers alike.
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Thalheimer, Markus
2011-01-01
In 2003 a new reimbursement system was established for German hospitals. The approximately 17 million inpatient cases per year are now reimbursed based on a per-case payment regarding diagnoses and procedures, which was developed from an internationally approved system. The aim was a better conformity of costs and efforts in in-patient cases. In the first 2 years after implementation, the German diagnosis-related group (DRG) system was not able to adequately represent the complex structures of treatment in hematological and oncological in-patients. By creating new diagnoses and procedures (International Classification of Diseases 10 (ICD-10) and Surgical Operations and Procedures Classification System (OPS) catalogues), generating new DRGs and better splitting of existing ones, the hematology and oncology field could be much better described in the following years. The implementation of about 70 'co-payment structures' for new and expensive drugs and procedures in oncology was also crucial. To reimburse innovations, an additional system of co-payments for innovations was established to bridge the time until innovations are represented within the DRG system itself. In summary, hematological and oncological in-patients, including cases with extraordinary costs, are meanwhile well mapped in the German reimbursement system. Any tendencies to rationing could thereby be avoided, as most of the established procedures and costly drugs are adequately represented in the DRG system. Copyright © 2011 S. Karger AG, Basel.
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75 FR 9184 - Federal Advisory Committee; Advisory Council on Dependents' Education; Open Meeting
2010-03-01
... 102-3.150, the Department of Defense announces that the Advisory Council on Dependents' Education will... Advisory Council on Dependents' Education about its mission and functions. Written statements may be... Advisory Council on Dependents' Education, Mr. Charles Toth, telephone (703) 588-3105, 4040 North Fairfax...
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77 FR 72365 - National Institute on Drug Abuse; Notice of Meeting
2012-12-05
... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... administrative, legislative and program developments in the drug abuse field. Place: National Institutes of... of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs...
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Poirier, A F; Murphy, W R
2016-12-01
The US Food and Drug Administration (FDA) Safety and Innovation Act (FDASIA, 2012) introduced the Breakthrough Therapy Designation (BTD), a new tool to expedite development of medicines to treat serious or life-threatening diseases. The majority of BTDs have gone to oncology drugs, and a recent publication by Shea et al. 1 reviewed the impact of BTD on oncology drug development. This article reviews the impact of BTD on development strategies and timelines for nononcology drugs. © 2016 American Society for Clinical Pharmacology and Therapeutics.
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2011-08-19
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-074)] NASA International Space Station Advisory Committee and the Aerospace Safety Advisory Panel; Meeting AGENCY: National Aeronautics and Space... meeting of the NASA International Space Station Advisory Committee and the Aerospace Safety Advisory Panel...
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Cardiac management of oncology patients clinical handbook for cardio-oncology
Baron Esquivias, Gonzalo
2015-01-01
This book is designed for clinical cardiologists and other physicians working with cardiac patients, where specific specialized teams of cardio-oncologists are not available and who are called to perform a clinical consultation to evaluate both the cardiac condition and the eligibility for chemotherapy or radiotherapy treatment, and to evaluate if a cancer treatment produces toxic effects on a patient treated with chemo or radiotherapy and if appearance of new symptoms is due to this treatment. In recent years, progress in oncologic therapy has resulted in important developments and the prognostic improvement of patients with malignancy. The cornerstone of chemotherapy are the anthracyclines (and the analogue Mitoxantrone), that are direct cellular toxic agents and that are among the most powerful anti-neoplastic drugs, but their cardiac toxicity is well known. Significant breakthroughs in cancer therapy have also been achieved with the introduction of signalling inhibitors, such as VEGF inhibitors, HERB2 inh...
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Biosimilars in the United States: Considerations for Oncology Advanced Practitioners
Mayden, Kelley D.; Larson, Paul; Geiger, Danielle; Watson, Holly
2015-01-01
Biosimilars will enter the US market soon, potentially lowering costs and increasing patient access to important oncology biologics. Biosimilars are highly similar, but not identical, to their reference product. Subtle variations arise due to their inherent complexity and differences in manufacturing. Biosimilars are not generic drugs. They will be approved through a separate US regulatory pathway?distinct from conventional biologics license applications?based on analytic and clinical studies...
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Industry Perspectives on Market Access of Innovative Drugs: The Relevance for Oncology Drugs
Pauwels, Kim; Huys, Isabelle; Casteels, Minne; Simoens, Steven
2016-01-01
Key Points - Representatives of the pharmaceutical industry call for a broader recognition of value within the assessment and appraisal of innovative drugs - Focus on value within the assessment and appraisal of drugs is jeopardized by financial drives as the side of industry and at the side of the payers - A well–considered value-framework, with attention for patient reported outcomes, societal preferences and dynamic approach on the drug life cycle, needs to be incorporated in ass...
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76 FR 51381 - National Institute on Drug Abuse; Notice of Meeting
2011-08-18
... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... administrative, legislative and program developments in the drug abuse field. Place: National Institutes of.... (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs...
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76 FR 81952 - National Institute on Drug Abuse; Notice of Meeting
2011-12-29
... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse..., legislative and program developments in the drug abuse field. Place: National Institutes of Health...: Teresa Levitin, Ph.D., Director, Office of Extramural Affairs, National Institute on Drug Abuse, NIH...
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75 FR 14176 - National Institute on Drug Abuse; Notice of Meeting
2010-03-24
... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... announcements and reports of administrative, legislative and program developments in the drug abuse field. Place... Person: Teresa Levitin, PhD, Director, Office of Extramural Affairs, National Institute on Drug Abuse...
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77 FR 52752 - National Institute on Drug Abuse; Notice of Meeting
2012-08-30
... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse..., legislative and program developments in the drug abuse field. Place: National Institutes of Health... Drug Abuse, NIH, DHHS, Room 4243, MSC 9550, 6001 Executive Boulevard, Bethesda, MD 20892-89550, (301...
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75 FR 42100 - National Institute on Drug Abuse; Notice of Meeting
2010-07-20
... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse..., legislative and program developments in the drug abuse field. Place: National Institutes of Health...: Teresa Levitin, PhD, Director, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS...
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2011-08-23
... DEPARTMENT OF DEFENSE Notice of Advisory Committee Closed Meeting; U.S. Strategic Command Strategic Advisory Group AGENCY: Department of Defense. ACTION: Notice of Advisory Committee closed meeting.... Strategic Command Strategic Advisory Group. DATES: November 1, 2011, from 8 a.m. to 5 p.m. and November 2...
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AMCP Partnership Forum: Driving Value and Outcomes in Oncology.
2017-05-01
Innovation in cancer treatment has provided a wealth of recently available therapeutic agents and a healthy drug pipeline that promises to change the way we approach this disease and the lives of those affected in the years to come. However, the majority of these new agents, many of which are targeted to specific genomic features of various tumors, may challenge the health care system's ability to afford cancer care. This innovation drives the need to focus on the value of the treatments provided to patients with cancer and on methods to optimize the efficiency of the dollars we spend, in addition to the clinical value itself. The Academy of Managed Care Pharmacy (AMCP) convened a Partnership Forum to address how to improve value and outcomes in cancer care. In this multistakeholder forum, several areas were addressed: current methods for assessing the value of oncology products, the need for balancing population management with precision medicine, and the outlook for value-based contracting for oncology medications in managed care settings. Participants recommended ways in which stakeholders can work toward solutions in these areas. The forum brought together stakeholders from health plans, integrated delivery systems, pharmacy benefit managers, clinical practice, biopharmaceutical industry, and laboratory companies. Also participating were representatives from trade and professional associations. During this 1.5-day forum, participants identified current challenges, readiness, and ways to address value and improve outcomes in cancer therapy. Some of the challenges identified include choosing a viable (and practical) outcome target for value-based contracting in oncology, the development and use of value frameworks and clinical pathways, managing cancer diagnostics, utilization of alternative payment systems, moving from a large evidence base to a small clinical trial base in considering targeted treatments, and lack of best practices in value-based payment
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Ignoffo, Robert; Knapp, Katherine; Barnett, Mitchell; Barbour, Sally Yowell; D'Amato, Steve; Iacovelli, Lew; Knudsen, Jasen; Koontz, Susannah E; Mancini, Robert; McBride, Ali; McCauley, Dayna; Medina, Patrick; O'Bryant, Cindy L; Scarpace, Sarah; Stricker, Steve; Trovato, James A
2016-04-01
With an aging US population, the number of patients who need cancer treatment will increase significantly by 2020. On the basis of a predicted shortage of oncology physicians, nonphysician health care practitioners will need to fill the shortfall in oncology patient visits, and nurse practitioners and physician assistants have already been identified for this purpose. This study proposes that appropriately trained oncology pharmacists can also contribute. The purpose of this study is to estimate the supply of Board of Pharmacy Specialties-certified oncology pharmacists (BCOPs) and their potential contribution to the care of patients with cancer through 2020. Data regarding accredited oncology pharmacy residencies, new BCOPs, and total BCOPs were used to estimate oncology residencies, new BCOPs, and total BCOPs through 2020. A Delphi panel process was used to estimate patient visits, identify patient care services that BCOPs could provide, and study limitations. By 2020, there will be an estimated 3,639 BCOPs, and approximately 62% of BCOPs will have completed accredited oncology pharmacy residencies. Delphi panelists came to consensus (at least 80% agreement) on eight patient care services that BCOPs could provide. Although the estimates given by our model indicate that BCOPs could provide 5 to 7 million 30-minute patient visits annually, sensitivity analysis, based on factors that could reduce potential visit availability resulted in 2.5 to 3.5 million visits by 2020 with the addition of BCOPs to the health care team. BCOPs can contribute to a projected shortfall in needed patient visits for cancer treatment. BCOPs, along with nurse practitioners and physician assistants could substantially reduce, but likely not eliminate, the shortfall of providers needed for oncology patient visits. Copyright © 2016 by American Society of Clinical Oncology.
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Psycho-oncology in Australia: a descriptive review.
Butow, P; Dhillon, H; Shaw, J; Price, M
2017-01-01
Australia has a thriving Psycho-Oncology research and clinical community. In this article, the Australian health system in which Psycho-Oncology is embedded is described. Clinical Psycho-Oncology services are outlined, in terms of their composition, processes and reach. The development of the internationally ground-breaking Australian Psychosocial guidelines for the care of adults with cancer is described. Two large Psycho-Oncology organisations which are strongly linked to mainstream Oncology organisations are discussed: the Australian Psycho-Oncology Society (OzPos, a primarily clinician-led and focused organisation) and the Psycho-Oncology Co-operative Research Group (PoCoG, a national cancer clinical trial group). OzPos is a special interest group within the Clinical Oncology Society of Australia, while PoCoG is one of 14 cancer clinical trial groups funded by the national government. It is these strong connections with major multidisciplinary cancer organisations, and a culture of collaboration and co-operation, that have made Psycho-Oncology grow and thrive in Australia. Examples of large collaborative programs of Psycho-Oncology research are provided, as well as the mechanisms used to achieve these outcomes.
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Clinical and Radiation Oncology. Vol. 2
International Nuclear Information System (INIS)
Jurga, L.; Adam, Z.; Autrata, R.
2010-01-01
The work is two-volume set and has 1,658 pages. It is divided into 5 sections: I. Principles Clinical and radiation oncology. II. Hematological Malignant tumors. III. Solid tumors. IV. Treatment options metastatic Disease. V. Clinical practice in oncology. Second volume contains following sections a chapters: Section III: Solid nodes, it contains following chapters: (38) Central nervous system tumors; (39) Tumors of the eye, orbits and adnexas; (40) Head and neck carcinomas; (41) Lung carcinomas and pleural mesothelioma; (42) Mediastinal tumors; (43) Tumors of the esophagus; (44) Gastric carcinomas; (45) Carcinoma of the colon, rectum and anus; (46) Small intestinal cancer; (47) Liver and biliary tract carcinomas; (48) Tumors of the pancreas; (49) Tumors of the kidney and upper urinary tract; (50) Bladder tumors of the bladder, urinary tract and penis; (51) Prostate Carcinoma; (52) Testicular tumors; (53) Malignant neoplasm of the cervix, vulva and vagina; (54) Endometrial carcinoma; (55) Malignant ovarian tumors; (56) Gestational trophoblastic disease; (57) Breast carcinoma - based on a evidence-based approach; (58) Thyroid and parathyroid carcinomas; (59) Dental tumors of endocrine glands; (60) Tumors of the locomotory system; (61) Malignant melanoma; (62) Carcinomas of the skin and skin adnexa; (63) Malignant tumors in immunosuppressed patients; (64) Tumors of unknown primary localization; (65) Children's oncology; (66) Geriatric Oncology; (67) Principles of long-term survival of patients with medically and socially significant types of malignant tumors after treatment. Section IV: Options of metastic disease disease, it contains following chapters: (68) Metastases to the central nervous system; (69) Metastases in the lungs; (70) Metastases in the liver; (71) Metastases into the skeleton. Section V: Clinical practice in oncology, it contains following chapters: (72) Acute conditions in oncology; (73) Prevention and management of radiation and chemical toxicity
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International Nuclear Information System (INIS)
Burmeister, Jay; Chen, Zhe; Chetty, Indrin J.; Dieterich, Sonja; Doemer, Anthony; Dominello, Michael M.; Howell, Rebecca M.; McDermott, Patrick; Nalichowski, Adrian; Prisciandaro, Joann; Ritter, Tim; Smith, Chadd; Schreiber, Eric; Shafman, Timothy; Sutlief, Steven; Xiao, Ying
2016-01-01
Purpose: The American Society for Radiation Oncology (ASTRO) Physics Core Curriculum Subcommittee (PCCSC) has updated the recommended physics curriculum for radiation oncology resident education to improve consistency in teaching, intensity, and subject matter. Methods and Materials: The ASTRO PCCSC is composed of physicists and physicians involved in radiation oncology residency education. The PCCSC updated existing sections within the curriculum, created new sections, and attempted to provide additional clinical context to the curricular material through creation of practical clinical experiences. Finally, we reviewed the American Board of Radiology (ABR) blueprint of examination topics for correlation with this curriculum. Results: The new curriculum represents 56 hours of resident physics didactic education, including a 4-hour initial orientation. The committee recommends completion of this curriculum at least twice to assure both timely presentation of material and re-emphasis after clinical experience. In addition, practical clinical physics and treatment planning modules were created as a supplement to the didactic training. Major changes to the curriculum include addition of Fundamental Physics, Stereotactic Radiosurgery/Stereotactic Body Radiation Therapy, and Safety and Incidents sections, and elimination of the Radiopharmaceutical Physics and Dosimetry and Hyperthermia sections. Simulation and Treatment Verification and optional Research and Development in Radiation Oncology sections were also added. A feedback loop was established with the ABR to help assure that the physics component of the ABR radiation oncology initial certification examination remains consistent with this curriculum. Conclusions: The ASTRO physics core curriculum for radiation oncology residents has been updated in an effort to identify the most important physics topics for preparing residents for careers in radiation oncology, to reflect changes in technology and practice since
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77 FR 22581 - National Institute on Drug Abuse; Notice of Meeting
2012-04-16
... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... developments in the drug abuse field. Place: National Institutes of Health, Neuroscience Center, 6001 Executive..., Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 4243, MSC 9550, 6001...
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The impact of the written request process on drug development in childhood cancer.
Snyder, Kristen M; Reaman, Gregory; Avant, Debbie; Pazdur, Richard
2013-04-01
The Food and Drug Administration (FDA) Modernization Act, enacted in 1997, created a pediatric exclusivity incentive allowing sponsors to qualify for an additional 6 months of marketing exclusivity after satisfying the requirements outlined in the Written Request (WR). This review evaluates the impact of the WR mechanism on the development of oncology drugs in children. A search of the FDA document archiving, reporting, and regulatory tracking system was performed for January 1, 2000 to December 31, 2010. Drugs were identified and pediatric-specific labeling information was obtained from Drugs@fda.gov and FDA Pediatric Labeling Changes Table. Fifty WRs have been issued for oncology drugs. Pediatric studies have been submitted for 14 drugs. Thirteen received pediatric exclusivity. As of December 31, 2010, labeling changes have been made for 11 drugs. Three drugs were approved for pediatric use. WRs have provided a mechanism to promote the study of drugs in pediatric malignancies. Information from studies resulting from the WRs regarding safety, pharmacokinetics, and tolerability of oncology drugs has been incorporated into pediatric labeling for 11/14 of the drugs. Earlier communication and collaboration between the FDA, National Cancer Institute, clinical investigators, and commercial sponsors are envisioned to facilitate the identification and prioritization of emerging new drugs of interest for WR consideration. Since this is the only regulatory mechanism, resulting from specific legislative initiatives relevant to cancer drug development for children, efforts to enhance its impact on increasing drug approval for pediatric cancer indications are warranted. Copyright © 2013 Wiley Periodicals, Inc.
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Lifescience Database Archive (English)
Full Text Available e COX2 inhibitor ... DG01907 ... Antiinflammatory drug, coxibs Chemical group: DG02333 ... Coxibs Treatment of pain and inflammation, oncolo...gy ... CAS: 197904-84-0 PubChem: 96025340 ChEMBL: CHEMBL1835207 LigandBox: D08657 ...
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Digitization and its discontents: future shock in predictive oncology.
Epstein, Richard J
2010-02-01
Clinical cancer care is being transformed by a high-technology informatics revolution fought out between the forces of personalized (biomarker-guided) and depersonalized (bureaucracy-controlled) medicine. Factors triggering this conflict include the online proliferation of treatment algorithms, rising prices of biological drug therapies, increasing sophistication of genomic-based predictive tools, and the growing entrepreneurialism of offshore treatment facilities. The resulting Napster-like forces unleashed within the oncology marketplace will deliver incremental improvements in cost-efficacy to global healthcare consumers. There will also be a price to pay, however, as the rising wave of digitization encourages third-party payers to make more use of biomarkers for tightening reimbursement criteria. Hence, as in other digitally transformed industries, a new paradigm of professional service delivery-less centered on doctor-patient relationships than in the past, and more dependent on pricing and marketing for standardized biomarker-defined indications-seems set to emerge as the unpredicted deliverable from this brave new world of predictive oncology. Copyright 2010 Elsevier Inc. All rights reserved.
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Aldaz, Bruno E; Treharne, Gareth J; Knight, Robert G; Conner, Tamlin S; Perez, David
2017-09-01
This study explored oncology healthcare professionals' perspectives on the psychosocial support needs of diverse cancer patients during oncology treatment. Six themes were identified using thematic analysis. Healthcare professionals highlighted the importance of their sensitivity, respect and emotional tact during appointments in order to effectively identify and meet the needs of oncology patients. Participants also emphasised the importance of building rapport that recognises patients as people. Patients' acceptance of treatment-related distress and uncertainty was described as required for uptake of available psychosocial supportive services. We offer some practical implications that may help improve cancer patients' experiences during oncology treatment.
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[The Necessity and the Current Status of Safe Handling of Anticancer Drugs].
Kanda, Kiyoko
2017-07-01
Number of people who handle anticancer drugs in their profession is increasing. Anticancer drugs, which are hazardous drugs(HD), exert cytocidal effects on cancer cells, but many have also been shown to have mutagenicity, teratogenicity and carcinogenicity; therefore, safe handling of anticancer drugs is necessary. In July 2015, the first Japanese guidelines for exposure control measures, namely, the "Joint Guidelines for Safe Handling of Cancer Chemotherapy Drugs", were published jointly by 3 societies. Our guideline is the creation of the Japanese Society of Cancer Nursing(JSCN), Japanese Society of Medical Oncology(JSMO)and Japanese Society of Pharmaceutical Oncology(JASPO)and has a historical significance. This paper states the necessity of safe handling of anticancer drugs, Japan's recent movement of safe handling, the introduction of joint guidelines of safe handling of anticancer drugs, and new movement of safe handling of USP chapter 800 in the United States.
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Gabardi, Steven; Baroletti, Steven A
2010-10-01
Everolimus, a proliferation signal inhibitor in the mammalian target of rapamycin (mTOR) drug class, has many clinical applications, including in organ transplantation, oncology, and cardiology. It currently has United States Food and Drug Administration (FDA) approval for prophylaxis against rejection in de novo renal transplant recipients, treatment of renal cell carcinoma, and use as a drug-eluting stent. To review the pharmacology, pharmacokinetics, efficacy, and safety of everolimus, we performed a search of the MEDLINE database (January 1997-April 2010) for all English-language articles of in vitro and in vivo studies that evaluated everolimus, as well as abstracts from recent scientific meetings and the manufacturer. In transplantation, everolimus demonstrates immunosuppressive properties and has been used to prevent acute rejection in cardiac, liver, lung, and renal transplant recipients. It appears that this agent may be potent enough to allow for the minimization or removal of calcineurin inhibitors in the long-term management of renal transplant recipients. In oncology, everolimus has been proven effective for the management of treatment-resistant renal cell carcinoma. In cardiology, everolimus is available as a drug-coated stent and is used in percutaneous coronary interventions for prevention of restenosis. In transplant recipients and patients with renal cell carcinoma, everolimus appears to have an extensive adverse-event profile. The pharmacologic properties of everolimus differentiate this agent from other drugs used in these clinical areas, and its pharmacokinetic properties differentiate it from sirolimus.
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International Nuclear Information System (INIS)
Anon.
1977-01-01
The Radiation Oncology Division has had as its main objectives both to operate an academic training program and to carry out research on radiation therapy of cancer. Since fiscal year 1975, following a directive from ERDA, increased effort has been given to research. The research activities have been complemented by the training program, which has been oriented toward producing radiation oncologists, giving physicians short-term experience in radiation oncology, and teaching medical students about clinical cancer and its radiation therapy. The purpose of the research effort is to improve present modalities of radiation therapy of cancer. As in previous years, the Division has operated as the Radiation Oncology Program of the Department of Radiological Sciences of the University of Puerto Rico School of Medicine. It has provided radiation oncology support to patients at the University Hospital and to academic programs of the University of Puerto Rico Medical Sciences Campus. The patients, in turn, have provided the clinical basis for the educational and research projects of the Division. Funding has been primarily from PRNC (approx. 40%) and from National Cancer Institute grants channeled through the School of Medicine (approx. 60%). Special inter-institutional relationships with the San Juan Veterans Administration Hospital and the Metropolitan Hospital in San Juan have permitted inclusion of patients from these institutions in the Division's research projects. Medical physics and radiotherapy consultations have been provided to the Radiotherapy Department of the VA Hospital
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Imaging Opportunities in Radiation Oncology
International Nuclear Information System (INIS)
Balter, James M.; Haffty, Bruce G.; Dunnick, N. Reed; Siegel, Eliot L.
2011-01-01
Interdisciplinary efforts may significantly affect the way that clinical knowledge and scientific research related to imaging impact the field of Radiation Oncology. This report summarizes the findings of an intersociety workshop held in October 2008, with the express purpose of exploring 'Imaging Opportunities in Radiation Oncology.' Participants from the American Society for Radiation Oncology (ASTRO), National Institutes of Health (NIH), Radiological Society of North America (RSNA), American Association of physicists in Medicine (AAPM), American Board of Radiology (ABR), Radiation Therapy Oncology Group (RTOG), European Society for Therapeutic Radiology and Oncology (ESTRO), and Society of Nuclear Medicine (SNM) discussed areas of education, clinical practice, and research that bridge disciplines and potentially would lead to improved clinical practice. Findings from this workshop include recommendations for cross-training opportunities within the allowed structured of Radiology and Radiation Oncology residency programs, expanded representation of ASTRO in imaging related multidisciplinary groups (and reciprocal representation within ASTRO committees), increased attention to imaging validation and credentialing for clinical trials (e.g., through the American College of Radiology Imaging Network (ACRIN)), and building ties through collaborative research as well as smaller joint workshops and symposia.
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Challenges in translating end points from trials to observational cohort studies in oncology
Directory of Open Access Journals (Sweden)
Ording AG
2016-06-01
Full Text Available Anne Gulbech Ording,1 Deirdre Cronin-Fenton,1 Vera Ehrenstein,1 Timothy L Lash,1,2 John Acquavella,1 Mikael Rørth,1 Henrik Toft Sørensen1 1Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark; 2Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA Abstract: Clinical trials are considered the gold standard for examining drug efficacy and for approval of new drugs. Medical databases and population surveillance registries are valuable resources for post-approval observational research, which are increasingly used in studies of benefits and risk of new cancer drugs. Here, we address the challenges in translating endpoints from oncology trials to observational studies. Registry-based cohort studies can investigate real-world safety issues – including previously unrecognized concerns – by examining rare endpoints or multiple endpoints at once. In contrast to clinical trials, observational cohort studies typically do not exclude real-world patients from clinical practice, such as old and frail patients with comorbidity. The observational cohort study complements the clinical trial by examining the effectiveness of interventions applied in clinical practice and by providing evidence on long-term clinical outcomes, which are often not feasible to study in a clinical trial. Various endpoints can be included in clinical trials, such as hard endpoints, soft endpoints, surrogate endpoints, and patient-reported endpoints. Each endpoint has it strengths and limitations for use in research studies. Endpoints used in oncology trials are often not applicable in observational cohort studies which are limited by the setting of standard clinical practice and by non-standardized endpoint determination. Observational studies can be more helpful moving research forward if they restrict focus to appropriate and valid endpoints. Keywords: endpoint determination, medical oncology
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78 FR 45252 - National Institute on Drug Abuse; Notice of Meeting
2013-07-26
... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... on Drug Abuse. Date: September 4, 2013. Closed: 8:30 AM to 10:30 AM. Agenda: To review and evaluate... program developments in the drug abuse field. Place: National Institutes of Health, Neuroscience Center...
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CNAM: care and treatment aboard in oncology
International Nuclear Information System (INIS)
Cherif, Leila; Bayoudh, L.; Riahi, S.; Zarrad, M.
2013-01-01
The Tunisian National Health Insurance Fund (TNHIF) has 186 practitioners and advisers (physicians, dentists and pharmacists) in the service of medical supervision. These advisers are distributed on three levels (regional, district and national). In the present paper we have discussed the CNAM support in the different types of oncology (FSD (Fully Supported Disorders), Hospitalization, the scans, the radiation therapy, specific drugs and treatment abroad). We begin by presenting expenditures by year and age group for FSD and hospitalization in the private and the public sectors. We then give the conventional packages for scans, radiotherapy: either for CLAM or CRAM. Daily benefits for the sickness leave and the disability will be presented briefly. Then we will give the administrative process for the approval of the commission for specific medication. The medical advice is based on certain criteria that will be explained in the paper. In certain cases definitive medical advice needs to call for the recommendation of a national commission and oncology or different experts. The spending trend of the TNHIF from 2001 to 2012 will be discussed. TNHIF generally considered Herceptin, Nexavar Erbitaux as the main drugs for targeted therapies. We present for the treatment cost and expenditure trends for the first drug from 2008 to 2012 as well as the estimation for 2013, which increases from one year to year. For the treatment with the second and the third drug we give the evolution of expenditure between 2010 and 2012. Cancer is a serious disease that requires a costly multidisciplinary support for the patients. This support has changed the prognosis survival (see cases of healing). The financial coverage of this support can never be supported by the family (whatever the wealth level) without any TNHIF support. The real gain in survival and expenditure control are closely related to awareness and early detection of the disease. TNHIF usually intervenes in the financing of
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Antineoplastic drugs: Occupational exposure and health risks
Fransman, W.
2006-01-01
Antineoplastic drugs are pharmaceuticals commonly used to treat cancer (and some non-neoplastic diseases), which are generally referred to as 'chemotherapy'. Oncology nurses are exposed to these drugs via the skin of hands during daily nursing activities, even when protective gloves are being used. Results of tests on bulk and surface contamination samples confirmed that patients intravenously treated with cyclophosphamide excrete the unmetabolized drug. The introduction of new guidelines and...
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Targeting the unmet medical need: the Abbott Laboratories oncology approach.
Carlson, Dawn M; Steinberg, Joyce L; Gordon, Gary
2005-09-01
While significant advances in the treatment of cancer occured during the last half of the twentieth century, parallel decreases in overall cancer death rates were not observed. Cancer therapy remains an area of significant unmet medical need. Abbott's oncology research programs are focused on pioneering trageted, less toxic therapies, aimed at different aspects of tumor growth and development. Oncology drugs in development at Abbott target several mechanisms of cancer progression by interfering with multiple processes necessary for tumor growth: recruitment of a blood supply, cell proliferation, and the development of metastases. They include a selective endothelin A-receptor antagonist (atrasentan/Xinlay), 3 angiogenesis inhibitors (ABT 510, a thrombospondin mimetic: ABT-869, a multitargeted receptor tyrosine kinase inhibitor; and ABT 828, recombinant human plasminogen kringle 5), a cell proliferation inhibitor (ABT-751, an antimitotic agent), an apoptosis inducer (ABT 737, a Bcl-2 family inhibitor), and a poly(ADP-ribose)polymerase inhibitor.
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2012-05-01
... DEPARTMENT OF DEFENSE Notice of Advisory Committee Closed Meeting; U.S. Strategic Command Strategic Advisory Group AGENCY: Department of Defense. ACTION: Notice of Advisory Committee closed meeting.... [[Page 25707
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Biosimilars: Considerations for Oncology Nurses .
Vizgirda, Vida; Jacobs, Ira
2017-04-01
Biosimilars are developed to be highly similar to and treat the same conditions as licensed biologics. As they are approved and their use becomes more widespread, oncology nurses should be aware of their development and unique considerations. This article reviews properties of biosimilars; their regulation and approval process; the ways in which their quality, safety, and efficacy are evaluated; their postmarketing safety monitoring; and their significance to oncology nurses and oncology nursing. . A search of PubMed and regulatory agency websites was conducted for references related to the development and use of biosimilars in oncology. . Because biologics are large, structurally complex molecules, biosimilars cannot be considered generic equivalents to licensed biologic products. Consequently, regulatory approval for biosimilars is different from approval for small-molecule generics. Oncology nurses are in a unique position to educate themselves, other clinicians, and patients and their families about biosimilars to ensure accurate understanding, as well as optimal and safe use, of biosimilars.
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Metabolic complications in oncology
International Nuclear Information System (INIS)
Sycova-Mila, Z.
2012-01-01
Currently, a lot of space and time is devoted to the therapy of oncologic diseases itself. To reach the good therapy results, complex care of the oncologic patient is needed. Management of complications linked with the disease itself and management of complications emerged after administration of chemotherapy, radiotherapy or targeted therapy, plays a significant role. In addition to infectious, hematological, neurological, cardiac or other complications, metabolic complications are relatively extensive and serious. One of the most frequent metabolic complications in oncology is tumor lysis syndrome, hyperuricemia, hypercalcaemia and syndrome of inappropriate secretion of antidiuretic hormone. (author)
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Innovations in radiation oncology
International Nuclear Information System (INIS)
Withers, H.R.
1988-01-01
The series 'Medical Radiology - Diagnostic Imaging and Radiation Oncology' is the successor to the well known 'Encyclopedia of Medical Radiology/Handbuch der medizinischen Radiologie'. 'Medical Radiology' brings the state of the art on special topics in a timely fashion. This volume 'Innovation in Radiation Oncology', edited by H.R. Withers and L.J. Peters, presents data on the development of new therapeutic strategies in different oncologic diseases. 57 authors wrote 32 chapters covering a braod range of topics. The contributors have written their chapters with the practicing radiation oncologist in mind. The first chapter sets the stage by reviewing the quality of radiation oncology as it is practiced in the majority of radiation oncology centers in the United States. The second chapter examines how we may better predict the possible causes of failure of conventional radiotherapy in order that the most appropriate of a variety of therapeutic options may eventually be offered to patients on an individual basis. The third chapter discussed how our therapeutic endeavors affect the quality of life, a problem created by our ability to be successful. Following these three introductory chapters there are 29 chapters by highly qualified specialists discussing the newest ideas in subjects of concern to the practicing radiation oncologist. With 111 figs
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Exercise Promotion in Geriatric Oncology.
Burhenn, Peggy S; Bryant, Ashley Leak; Mustian, Karen M
2016-09-01
Evidence of the benefits of exercise for people with cancer from diagnosis through survivorship is growing. However, most cancers occur in older adults and little exercise advice is available for making specific recommendations for older adults with cancer. Individualized exercise prescriptions are safe, feasible, and beneficial for the geriatric oncology population. Oncology providers must be equipped to discuss the short- and long-term benefits of exercise and assist older patients in obtaining appropriate exercise prescriptions. This review provides detailed information about professionals and their roles as it relates to functional assessment, intervention, and evaluation of the geriatric oncology population. This review addresses the importance of functional status assessment and appropriate referrals to other oncology professionals.
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Geriatric Oncology Program Development and Gero-Oncology Nursing.
Lynch, Mary Pat; DeDonato, Dana Marcone; Kutney-Lee, Ann
2016-02-01
To provide a critical analysis of current approaches to the care of older adults with cancer, outline priority areas for geriatric oncology program development, and recommend strategies for improvement. Published articles and reports between 1999 and 2015. Providing an interdisciplinary model that incorporates a holistic geriatric assessment will ensure the delivery of patient-centered care that is responsive to the comprehensive needs of older patients. Nursing administrators and leaders have both an opportunity and responsibility to shape the future of geriatric oncology. Preparations include workforce development and the creation of programs that are designed to meet the complex needs of this population. Copyright © 2015 Elsevier Inc. All rights reserved.
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Continuing medical education in radiation oncology
International Nuclear Information System (INIS)
Chauvet, B.; Barillot, I.; Denis, F.; Cailleux, P.E.; Ardiet, J.M.; Mornex, F.
2012-01-01
In France, continuing medical education (CME) and professional practice evaluation (PPE) became mandatory by law in July 2009 for all health professionals. Recently published decrees led to the creation of national specialty councils to implement this organizational device. For radiation oncology, this council includes the French Society for Radiation Oncology (SFRO), the National Radiation Oncology Syndicate (SNRO) and the Association for Continuing Medical Education in Radiation Oncology (AFCOR). The Radiation Oncology National Council will propose a set of programs including CME and PPE, professional thesaurus, labels for CME actions consistent with national requirements, and will organize expertise for public instances. AFCOR remains the primary for CME, but each practitioner can freely choose an organisation for CME, provided that it is certified by the independent scientific commission. The National Order for physicians is the control authority. Radiation oncology has already a strong tradition of independent CME that will continue through this major reform. (authors)
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Complementary and Alternative Medicine: A Clinical Study in 1,016 Hematology/Oncology Patients.
Hierl, Marina; Pfirstinger, Jochen; Andreesen, Reinhard; Holler, Ernst; Mayer, Stephanie; Wolff, Daniel; Vogelhuber, Martin
2017-01-01
Surveys state a widespread use of complementary and alternative medicine (CAM) in patients with malignant diseases. CAM methods might potentially interfere with the metabolization of tumor-specific therapy. However, there is little communication about CAM use in hematology/oncology patients between patients, CAM providers, and oncologists. A self-administered questionnaire was handed out to all patients attending to the hematology/oncology outpatient clinic of Regensburg University Hospital. Subsequently, a chart review of all CAM users was performed. Questionnaires of 1,016 patients were analyzed. Of these patients, 30% used CAM, preferably vitamins and micronutrients. Main information sources for CAM methods were physicians/nonmedical practitioners and friends/relatives. CAM therapies were provided mainly by licensed physicians (29%), followed by nonmedical practitioners (14%) and the patients themselves (13%). Although 62% of the CAM users agreed that the oncologist may know about their CAM therapy, a chart entry about CAM use was found only in 41%. CAM is frequently used by hematology/oncology patients. Systematic communication about CAM is essential to avoid possible drug interactions. © 2017 S. Karger AG, Basel.
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Song, Hannah; Robinson, Sarah N; Huang, Jennifer T
2017-11-01
The impact of dermatology consultation on the care of children with oncologic conditions is unknown. To review outpatient dermatology visits and the resulting impact on diagnosis and management of pediatric oncology patients. Retrospective review of pediatric oncology patients with outpatient dermatology visits at a tertiary care center from 2008 to 2015. The most common dermatologic diagnoses in 516 patients were skin infections (21.3%) and nonmalignant skin eruptions (33.4%). A diagnosis of significant impact (ie, malignancy, adverse cutaneous drug reaction, graft-versus-host disease, varicella-zoster virus, or herpes simplex virus infection), was made at the dermatology clinic in 14.7% of visits. Consultation resulted in a change in diagnosis in 59.8% of patients, change in dermatologic management in 72.4% of patients, and change in management of noncutaneous issues in 12.4% of patients. The use of electronic medical records, the nongeneralizable study population, and the retrospective design represent potential limitations. Outpatient dermatology consultation can affect the care of pediatric oncology patients with respect to diagnosis and treatment of skin conditions and management of nondermatologic issues. Copyright © 2017 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.
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Takiguchi, Yuichi; Sekine, Ikuo; Iwasawa, Shunichiro; Kurimoto, Ryota; Sakaida, Emiko; Tamura, Kenji
2014-07-01
Medical oncology in Japan has a relatively short history, with specialist certification starting in 2006, resulting in 867 certified medical oncologists as of 2014. Although the national government has appointed 397 Designated Cancer Care Hospitals, little is known about the actual situations of medical oncology services at these institutions. Questionnaires regarding the presence of a medical oncology department, the number of physicians in the department, the presence of certified medical oncologists and the degree of the medical oncologists' responsibilities for drug therapies in adults with solid cancers were sent to all 397 institutions between 21 January and 1 May 2013. The response rate was 68.0%. Among the responses, 39.4% of the institutions had medical oncology departments with a median of three physicians. Most of the medical oncology departments were primarily responsible, as evaluated according to patient number, for the treatment of limited disease categories. The medical oncologists were significantly more responsible for molecular-targeted therapy than for chemotherapy in head and neck cancer or for cytokine therapy in renal cell carcinoma. The wide variety of adverse events associated with molecular-targeted therapy might have enhanced the roles of medical oncologists. As the proportion of hospitals with a medical oncology department increased according to the number of certified medical oncologists working at the institution, cultivating medical oncologists seems to be an urgent task for advancing medical oncology in Japan. The present study provides fundamental data for the future development of medical oncology in Japan. The present study is to uncover the current situation of medical oncology in Japan. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.
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Palliative Care: Delivering Comprehensive Oncology Nursing Care.
Dahlin, Constance
2015-11-01
To describe palliative care as part of comprehensive oncology nursing care. A review of the palliative care, oncology, and nursing literature over the past 10 years. Palliative care is mandated as part of comprehensive cancer care. A cancer diagnosis often results in distress in the physical, psychosocial, spiritual, and emotional domains of care. Oncology nurses are essential in providing palliative care from diagnosis to death to patients with cancer. They address the myriad aspects of cancer. With palliative care skills and knowledge, oncology nurses can provide quality cancer care. There are many opportunities in which oncology nurses can promote palliative care. Oncology nurses must obtain knowledge and skills in primary palliative care to provide comprehensive cancer care. Copyright © 2015 Elsevier Inc. All rights reserved.
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Kim, Won-Hyoung; Bae, Jae-Nam; Lim, Joohan; Lee, Moon-Hee; Hahm, Bong-Jin; Yi, Hyeon Gyu
2018-03-01
This study was performed to identify relationships between physicians' perceived stigma toward depression and psycho-oncology service utilization on an oncology/hematology ward. The study participants were 235 patients in an oncology/hematology ward and 14 physicians undergoing an internal medicine residency training program in Inha University Hospital (Incheon, South Korea). Patients completed the Patient Health Questionnaire-9 (PHQ-9), and residents completed the Perceived Devaluation-Discrimination scale that evaluates perceived stigma toward depression. A total PHQ-9 score of ≥5 was defined as clinically significant depression. Physicians decided on referral on the basis of their opinions and those of their patients. The correlates of physicians' recommendation for referral to psycho-oncology services and real referrals psycho-oncology services were examined. Of the 235 patients, 143 had PHQ-9 determined depression, and of these 143 patients, 61 received psycho-oncology services. Physicians recommended that 87 patients consult psycho-oncology services. Multivariate analyses showed that lower physicians' perceived stigma regarding depression was significantly associated with physicians' recommendation for referral, and that real referral to psycho-oncology services was significantly associated with presence of a hematologic malignancy and lower physicians' perceived stigma toward depression. Physicians' perceived stigma toward depression was found to be associated with real referral to psycho-oncology services and with physician recommendation for referral to psycho-oncology services. Further investigations will be needed to examine how to reduce physicians' perceived stigma toward depression. Copyright © 2017 John Wiley & Sons, Ltd.
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Oncology patient-reported claims: maximising the chance for success.
Kitchen, H; Rofail, D; Caron, M; Emery, M-P
2011-01-01
To review Patient Reported Outcome (PRO) labelling claims achieved in oncology in Europe and in the United States and consider the benefits, and challenges faced. PROLabels database was searched to identify oncology products with PRO labelling approved in Europe since 1995 or in the United States since 1998. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) websites and guidance documents were reviewed. PUBMED was searched for articles on PRO claims in oncology. Among all oncology products approved, 22 were identified with PRO claims; 10 in the United States, 7 in Europe, and 5 in both. The language used in the labelling was limited to benefit (e.g. "…resulted in symptom benefits by significantly prolonging time to deterioration in cough, dyspnoea, and pain, versus placebo") and equivalence (e.g. "no statistical differences were observed between treatment groups for global QoL"). Seven products used a validated HRQoL tool; two used symptom tools; two used both; seven used single-item symptom measures (one was unknown). The following emerged as likely reasons for success: ensuring systematic PRO data collection; clear rationale for pre-specified endpoints; adequately powered trials to detect differences and clinically significant changes; adjusting for multiplicity; developing an a priori statistical analysis plan including primary and subgroup analyses, dealing with missing data, pooling multiple-site data; establishing clinical versus statistical significance; interpreting failure to detect change. End-stage patient drop-out rates and cessation of trials due to exceptional therapeutic benefit pose significant challenges to demonstrating treatment PRO improvement. PRO labelling claims demonstrate treatment impact and the trade-off between efficacy and side effects ultimately facilitating product differentiation. Reliable and valid instruments specific to the desired language, claim, and target population are required. Practical
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2012-10-19
... ENVIRONMENTAL PROTECTION AGENCY [FRL--9743-2] Notification of a Public Teleconference of the Science Advisory Board; Perchlorate Advisory Panel AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The Environmental Protection Agency (EPA) Science Advisory Board (SAB) Staff Office...
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International Nuclear Information System (INIS)
Jagsi, Reshma; Bekelman, Justin E.; Brawley, Otis W.; Deasy, Joseph O.; Le, Quynh-Thu; Michalski, Jeff M.; Movsas, Benjamin; Thomas, Charles R.; Lawton, Colleen A.; Lawrence, Theodore S.; Hahn, Stephen M.
2012-01-01
Purpose: To promote the rational use of scarce research funding, scholars have developed methods for the systematic identification and prioritization of health research needs. The Radiation Oncology Institute commissioned an independent, comprehensive assessment of research needs for the advancement of radiation oncology care. Methods and Materials: The research needs assessment used a mixed-method, qualitative and quantitative social scientific approach, including structured interviews with diverse stakeholders, focus groups, surveys of American Society for Radiation Oncology (ASTRO) members, and a prioritization exercise using a modified Delphi technique. Results: Six co-equal priorities were identified: (1) Identify and develop communication strategies to help patients and others better understand radiation therapy; (2) Establish a set of quality indicators for major radiation oncology procedures and evaluate their use in radiation oncology delivery; (3) Identify best practices for the management of radiation toxicity and issues in cancer survivorship; (4) Conduct comparative effectiveness studies related to radiation therapy that consider clinical benefit, toxicity (including quality of life), and other outcomes; (5) Assess the value of radiation therapy; and (6) Develop a radiation oncology registry. Conclusions: To our knowledge, this prioritization exercise is the only comprehensive and methodologically rigorous assessment of research needs in the field of radiation oncology. Broad dissemination of these findings is critical to maximally leverage the impact of this work, particularly because grant funding decisions are often made by committees on which highly specialized disciplines such as radiation oncology are not well represented.
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Heslop, Emma; Csimma, Cristina; Straub, Volker; McCall, John; Nagaraju, Kanneboyina; Wagner, Kathryn R; Caizergues, Didier; Korinthenberg, Rudolf; Flanigan, Kevin M; Kaufmann, Petra; McNeil, Elizabeth; Mendell, Jerry; Hesterlee, Sharon; Wells, Dominic J; Bushby, Kate
2015-04-23
Despite multiple publications on potential therapies for neuromuscular diseases (NMD) in cell and animal models only a handful reach clinical trials. The ability to prioritise drug development according to objective criteria is particularly critical in rare diseases with large unmet needs and a limited numbers of patients who can be enrolled into clinical trials. TREAT-NMD Advisory Committee for Therapeutics (TACT) was established to provide independent and objective guidance on the preclinical and development pathway of potential therapies (whether novel or repurposed) for NMD.We present our experience in the establishment and operation of the TACT. TACT provides a unique resource of recognized experts from multiple disciplines. The goal of each TACT review is to help the sponsor to position the candidate compound along a realistic and well-informed plan to clinical trials, and eventual registration. The reviews and subsequent recommendations are focused on generating meaningful and rigorous data that can enable clear go/no-go decisions and facilitate longer term funding or partnering opportunities. The review process thereby acts to comment on viability, de-risking the process of proceeding on a development programme.To date TACT has held 10 review meeting and reviewed 29 program applications in several rare neuromuscular diseases: Of the 29 programs reviewed, 19 were from industry and 10 were from academia; 15 were for novel compounds and 14 were for repurposed drugs; 16 were small molecules and 13 were biologics; 14 were preclinical stage applications and 15 were clinical stage applications. 3 had received Orphan drug designation from European Medicines Agency and 3 from Food and Drug Administration. A number of recurrent themes emerged over the course of the reviews and we found that applicants frequently require advice and education on issues concerned with preclinical standard operating procedures, interactions with regulatory agencies, formulation
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Black Hawk Coll., Moline, IL.
An advisory committee is generally comprised of persons outside the education profession who have specialized knowledge in a given area. The committee advises, makes recommendations, and gives service to the college and its students, instructors, and administrators. At Black Hawk College, there are four types of advisory committees: community,…
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A Comprehensive Definition for Integrative Oncology.
Witt, Claudia M; Balneaves, Lynda G; Cardoso, Maria J; Cohen, Lorenzo; Greenlee, Heather; Johnstone, Peter; Kücük, Ömer; Mailman, Josh; Mao, Jun J
2017-11-01
Integrative oncology, which is generally understood to refer to the use of a combination of complementary medicine therapies in conjunction with conventional cancer treatments, has been defined in different ways, but there is no widely accepted definition. We sought to develop and establish a consensus for a comprehensive definition of the field of integrative oncology. We used a mixed-methods approach that included a literature analysis and a consensus procedure, including an interdisciplinary expert panel and surveys, to develop a comprehensive and acceptable definition for the term "integrative oncology." The themes identified in the literature and from the expert discussion were condensed into a two-sentence definition. Survey respondents had very positive views on the draft definition, and their comments helped to shape the final version. The final definition for integrative oncology is: "Integrative oncology is a patient-centered, evidence-informed field of cancer care that utilizes mind and body practices, natural products, and/or lifestyle modifications from different traditions alongside conventional cancer treatments. Integrative oncology aims to optimize health, quality of life, and clinical outcomes across the cancer care continuum and to empower people to prevent cancer and become active participants before,during, and beyond cancer treatment." This short and comprehensive definition for the term integrative oncology will facilitate a better understanding and communication of this emerging field. This definition will also drive focused and cohesive effort to advance the field of integrative oncology. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.
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International Nuclear Information System (INIS)
Howman Giles, R.; Bernard, E.; Uren, R.
1997-01-01
Nuclear medicine plays an important and increasing role in the management of childhood malignancy. This is particularly true in the solid tumours of childhood. It is also helpful in the management of the complications of cancer treatment such as the infections which often accompany immune suppression in oncology patients. Scintigraphy is a complementary investigation to other radiological techniques and adds the functional dimension to anatomical investigations such as CT, MRI and ultrasound. In selected malignancies radionuclides are also used in treatment. This review discusses the technical considerations relating to children and the specific techniques relating to pediatric oncology. Specific tumours and the various applications of radionuclides are discussed in particular lymphoma, primary bone tumours, soft tissue sarcomas, neuroblastoma, Wilms' tumour, brain tumours and leukemia. Uncommon tumours are also discussed and how radionuclides are useful in the investigation of various complications which occur in oncology patients
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Energy Technology Data Exchange (ETDEWEB)
Burmeister, Jay, E-mail: burmeist@karmanos.org [Department of Oncology, Karmanos Cancer Center/Wayne State University, Detroit, Michigan (United States); Chen, Zhe [Department of Therapeutic Radiology, Yale University, New Haven, Connecticut (United States); Chetty, Indrin J. [Department of Radiation Oncology, Henry Ford Hospital, Detroit, Michigan (United States); Dieterich, Sonja [Department of Radiation Oncology, University of California – Davis, Sacramento, California (United States); Doemer, Anthony [Department of Radiation Oncology, Henry Ford Hospital, Detroit, Michigan (United States); Dominello, Michael M. [Department of Oncology, Karmanos Cancer Center/Wayne State University, Detroit, Michigan (United States); Howell, Rebecca M. [Department of Radiation Physics, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); McDermott, Patrick [Department of Radiation Oncology, Beaumont Health, Royal Oak, Michigan (United States); Nalichowski, Adrian [Karmanos Cancer Center, Detroit, Michigan (United States); Prisciandaro, Joann [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Ritter, Tim [VA Ann Arbor Healthcare and the University of Michigan, Ann Arbor, Michigan (United States); Smith, Chadd [Department of Radiation Oncology, Henry Ford Hospital, Detroit, Michigan (United States); Schreiber, Eric [Department of Radiation Oncology, University of North Carolina, Chapel Hill, North Carolina (United States); Shafman, Timothy [21st Century Oncology, Fort Myers, Florida (United States); Sutlief, Steven [Department of Radiation Oncology, University of California – San Diego, La Jolla, California (United States); Xiao, Ying [Department of Radiation Oncology, Thomas Jefferson University, Philadelphia, Pennsylvania (United States)
2016-07-15
Purpose: The American Society for Radiation Oncology (ASTRO) Physics Core Curriculum Subcommittee (PCCSC) has updated the recommended physics curriculum for radiation oncology resident education to improve consistency in teaching, intensity, and subject matter. Methods and Materials: The ASTRO PCCSC is composed of physicists and physicians involved in radiation oncology residency education. The PCCSC updated existing sections within the curriculum, created new sections, and attempted to provide additional clinical context to the curricular material through creation of practical clinical experiences. Finally, we reviewed the American Board of Radiology (ABR) blueprint of examination topics for correlation with this curriculum. Results: The new curriculum represents 56 hours of resident physics didactic education, including a 4-hour initial orientation. The committee recommends completion of this curriculum at least twice to assure both timely presentation of material and re-emphasis after clinical experience. In addition, practical clinical physics and treatment planning modules were created as a supplement to the didactic training. Major changes to the curriculum include addition of Fundamental Physics, Stereotactic Radiosurgery/Stereotactic Body Radiation Therapy, and Safety and Incidents sections, and elimination of the Radiopharmaceutical Physics and Dosimetry and Hyperthermia sections. Simulation and Treatment Verification and optional Research and Development in Radiation Oncology sections were also added. A feedback loop was established with the ABR to help assure that the physics component of the ABR radiation oncology initial certification examination remains consistent with this curriculum. Conclusions: The ASTRO physics core curriculum for radiation oncology residents has been updated in an effort to identify the most important physics topics for preparing residents for careers in radiation oncology, to reflect changes in technology and practice since
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2010-06-14
... Closed Meetings of the Science Advisory Board's Scientific and Technological Achievement Awards Committee... Agency's (EPA), Science Advisory Board (SAB) Staff Office announces a meeting and teleconference of the....gov . The SAB Mailing address is: U.S. EPA Science Advisory Board (1400F), U.S. Environmental...
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Directory of Open Access Journals (Sweden)
Joy Kish
2014-10-01
Full Text Available The purpose of this study was to determine the characteristics and motivational factors of effective Extension advisory leaders. This Delphi study was conducted with a selected group of County Extension Directors and a group of Extension State Advisory Leaders. The study identified 10 characteristics that distinguish an effective Extension advisory leader. Some of these characteristics are explicit and easy to observe, while others are implicit and difficult to directly observe. Therefore, it is practical to use directly observable characteristics of effective advisory leaders when selecting volunteers. Once potential volunteers are spotted in the community, implicit characteristics of effective advisory leaders should be used to further screen them before they are selected. The study also identified the eight most important factors motivating individuals to volunteer as effective advisory leaders. Understanding these motivational factors is helpful for creating an environment for attracting and retaining effective volunteers. Understanding their motivation for volunteer work and creating an environment for them to meet the motivating factors for volunteering will lead to volunteer satisfaction and retention. The findings of this study can be used to build strong Extension advisory councils.
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2011-07-27
... Closed Meetings of the Science Advisory Board's Scientific and Technological Achievement Awards Committee... Agency's (EPA), Science Advisory Board (SAB) Staff Office announces a meeting and teleconference of the[email protected] . The SAB Mailing address is: U.S. EPA Science Advisory Board (1400R), U.S. Environmental...
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The Danish Neuro-Oncology Registry
DEFF Research Database (Denmark)
Hansen, Steinbjørn
2016-01-01
AIM OF DATABASE: The Danish Neuro-Oncology Registry (DNOR) was established by the Danish Neuro-Oncology Group as a national clinical database. It was established for the purpose of supporting research and development in adult patients with primary brain tumors in Denmark. STUDY POPULATION: DNOR has...... advantage of reporting indicators is the related multidisciplinary discussions giving a better understanding of what actually is going on, thereby facilitating the work on adjusting the national guidelines in the Danish Neuro-Oncology Group. CONCLUSION: The establishment of DNOR has optimized the quality...
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Energy Technology Data Exchange (ETDEWEB)
Jagsi, Reshma, E-mail: rjagsi@med.umich.edu [Department of Radiation Oncology, University of Michigan, Ann Arbor, MI (United States); Bekelman, Justin E. [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA (United States); Brawley, Otis W. [Department of Hematology and Oncology, Emory University, and American Cancer Society, Atlanta, Georgia (United States); Deasy, Joseph O. [Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY (United States); Le, Quynh-Thu [Department of Radiation Oncology, Stanford University, Stanford, CA (United States); Michalski, Jeff M. [Department of Radiation Oncology, Washington University, St. Louis, MO (United States); Movsas, Benjamin [Department of Radiation Oncology, Henry Ford Health System, Detroit, MI (United States); Thomas, Charles R. [Department of Radiation Oncology, Oregon Health and Sciences University, Portland, OR (United States); Lawton, Colleen A. [Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, WI (United States); Lawrence, Theodore S. [Department of Radiation Oncology, University of Michigan, Ann Arbor, MI (United States); Hahn, Stephen M. [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA (United States)
2012-10-01
Purpose: To promote the rational use of scarce research funding, scholars have developed methods for the systematic identification and prioritization of health research needs. The Radiation Oncology Institute commissioned an independent, comprehensive assessment of research needs for the advancement of radiation oncology care. Methods and Materials: The research needs assessment used a mixed-method, qualitative and quantitative social scientific approach, including structured interviews with diverse stakeholders, focus groups, surveys of American Society for Radiation Oncology (ASTRO) members, and a prioritization exercise using a modified Delphi technique. Results: Six co-equal priorities were identified: (1) Identify and develop communication strategies to help patients and others better understand radiation therapy; (2) Establish a set of quality indicators for major radiation oncology procedures and evaluate their use in radiation oncology delivery; (3) Identify best practices for the management of radiation toxicity and issues in cancer survivorship; (4) Conduct comparative effectiveness studies related to radiation therapy that consider clinical benefit, toxicity (including quality of life), and other outcomes; (5) Assess the value of radiation therapy; and (6) Develop a radiation oncology registry. Conclusions: To our knowledge, this prioritization exercise is the only comprehensive and methodologically rigorous assessment of research needs in the field of radiation oncology. Broad dissemination of these findings is critical to maximally leverage the impact of this work, particularly because grant funding decisions are often made by committees on which highly specialized disciplines such as radiation oncology are not well represented.
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Parke, Tom; Marchenko, Olga; Anisimov, Vladimir; Ivanova, Anastasia; Jennison, Christopher; Perevozskaya, Inna; Song, Guochen
2017-01-01
Designing an oncology clinical program is more challenging than designing a single study. The standard approaches have been proven to be not very successful during the last decade; the failure rate of Phase 2 and Phase 3 trials in oncology remains high. Improving a development strategy by applying innovative statistical methods is one of the major objectives of a drug development process. The oncology sub-team on Adaptive Program under the Drug Information Association Adaptive Design Scientific Working Group (DIA ADSWG) evaluated hypothetical oncology programs with two competing treatments and published the work in the Therapeutic Innovation and Regulatory Science journal in January 2014. Five oncology development programs based on different Phase 2 designs, including adaptive designs and a standard two parallel arm Phase 3 design were simulated and compared in terms of the probability of clinical program success and expected net present value (eNPV). In this article, we consider eight Phase2/Phase3 development programs based on selected combinations of five Phase 2 study designs and three Phase 3 study designs. We again used the probability of program success and eNPV to compare simulated programs. For the development strategies, we considered that the eNPV showed robust improvement for each successive strategy, with the highest being for a three-arm response adaptive randomization design in Phase 2 and a group sequential design with 5 analyses in Phase 3.
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78 FR 27411 - National Institute on Drug Abuse Notice of Closed Meetings
2013-05-10
... funding cycle. (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction... Abuse Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as... clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse...
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77 FR 58855 - National Institute on Drug Abuse Notice of Closed Meetings
2012-09-24
....gov . (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction... Abuse Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis...
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78 FR 19499 - National Institute on Drug Abuse; Notice of Closed Meeting
2013-04-01
... . (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs... Abuse; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Profile...
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75 FR 25278 - National Institute on Drug Abuse; Notice of Closed Meeting
2010-05-07
..., MD 21224, (410) 550-1547. (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse... Abuse; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as... conducted by the National Institute on Drug Abuse, including consideration of personnel qualifications and...
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76 FR 31967 - National Institute On Drug Abuse; Notice of Closed Meetings
2011-06-02
...: National Institute on Drug Abuse Special Emphasis Panel; Predictive Animal Models for Smoking Cessation... Abuse; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis...
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2010-03-12
... ENVIRONMENTAL PROTECTION AGENCY [FRL-9126-2] Science Advisory Board Staff Office; Notification of a Public Meeting of the Science Advisory Board (SAB) AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The Environmental Protection Agency (EPA) Science Advisory Board (SAB) Staff...
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Communication competencies of oncology nurses in Malaysia.
Maskor, Nor Aida; Krauss, Steven Eric; Muhamad, Mazanah; Nik Mahmood, Nik Hasnaa
2013-01-01
This paper reports on part of a large study to identify competencies of oncology nurses in Malaysia. It focuses on oncology nurses' communications-related competency. As an important cancer care team member, oncology nurses need to communicate effectively with cancer patients. Literature shows that poor communication can make patients feel anxious, uncertain and generally not satisfied with their nurses' care. This paper deliberates on the importance of effective communication by oncology nurses in the context of a public hospital. Four focus group discussions were used in this study with 17 oncology/cancer care nurses from Malaysian public hospitals. The main inclusion criterion was that the nurses had to have undergone a post-basic course in oncology, or have work experience as a cancer care nurse. The findings indicated that nurses do communicate with their patients, patients' families and doctors to provide information about the disease, cancer treatment, disease recurrence and side effects. Nurses should have good communication skills in order to build relationships as well as to provide quality services to their patients. The paper concludes by recommending how oncology nursing competencies can be improved.
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Labeling for Big Data in radiation oncology: The Radiation Oncology Structures ontology.
Bibault, Jean-Emmanuel; Zapletal, Eric; Rance, Bastien; Giraud, Philippe; Burgun, Anita
2018-01-01
Leveraging Electronic Health Records (EHR) and Oncology Information Systems (OIS) has great potential to generate hypotheses for cancer treatment, since they directly provide medical data on a large scale. In order to gather a significant amount of patients with a high level of clinical details, multicenter studies are necessary. A challenge in creating high quality Big Data studies involving several treatment centers is the lack of semantic interoperability between data sources. We present the ontology we developed to address this issue. Radiation Oncology anatomical and target volumes were categorized in anatomical and treatment planning classes. International delineation guidelines specific to radiation oncology were used for lymph nodes areas and target volumes. Hierarchical classes were created to generate The Radiation Oncology Structures (ROS) Ontology. The ROS was then applied to the data from our institution. Four hundred and seventeen classes were created with a maximum of 14 children classes (average = 5). The ontology was then converted into a Web Ontology Language (.owl) format and made available online on Bioportal and GitHub under an Apache 2.0 License. We extracted all structures delineated in our department since the opening in 2001. 20,758 structures were exported from our "record-and-verify" system, demonstrating a significant heterogeneity within a single center. All structures were matched to the ROS ontology before integration into our clinical data warehouse (CDW). In this study we describe a new ontology, specific to radiation oncology, that reports all anatomical and treatment planning structures that can be delineated. This ontology will be used to integrate dosimetric data in the Assistance Publique-Hôpitaux de Paris CDW that stores data from 6.5 million patients (as of February 2017).
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5 CFR 724.403 - Advisory guidelines.
2010-01-01
... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Advisory guidelines. 724.403 Section 724.403 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS... RETALIATION ACT OF 2002 Best Practices § 724.403 Advisory guidelines. OPM will issue advisory guidelines to...
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International Nuclear Information System (INIS)
Hirsch, Ariel E.; Mulleady Bishop, Pauline; Dad, Luqman; Singh, Deeptej; Slanetz, Priscilla J.
2009-01-01
Purpose: The Oncology Education Initiative was created to advance oncology and radiation oncology education by integrating structured didactics into the existing core radiology clerkship. We set out to determine whether the addition of structured didactics could lead to a significant increase in overall medical student knowledge about radiation oncology. Methods and Materials: We conducted a pre- and posttest examining concepts in general radiation oncology, breast cancer, and prostate cancer. The 15-question, multiple-choice exam was administered before and after a 1.5-hour didactic lecture by an attending physician in radiation oncology. Individual question changes, overall student changes, and overall categorical changes were analyzed. All hypothesis tests were two-tailed (significance level 0.05). Results: Of the 153 fourth-year students, 137 (90%) took the pre- and posttest and were present for the didactic lecture. The average test grade improved from 59% to 70% (p = 0.011). Improvement was seen in all questions except clinical vignettes involving correct identification of TNM staging. Statistically significant improvement (p ≤ 0.03) was seen in the questions regarding acute and late side effects of radiation, brachytherapy for prostate cancer, delivery of radiation treatment, and management of early-stage breast cancer. Conclusions: Addition of didactics in radiation oncology significantly improves medical students' knowledge of the topic. Despite perceived difficulty in teaching radiation oncology and the assumption that it is beyond the scope of reasonable knowledge for medical students, we have shown that even with one dedicated lecture, students can learn and absorb general principles regarding radiation oncology
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Energy Technology Data Exchange (ETDEWEB)
Schober, Otmar; Riemann, Burkhard (eds.) [Universitaetsklinikum Muenster (Germany). Klinik fuer Nuklearmedizin
2013-02-01
Considers in detail all aspects of molecular imaging in oncology, ranging from basic research to clinical applications in the era of evidence-based medicine. Examines technological issues and probe design. Discusses preclinical studies in detail, with particular attention to multimodality imaging. Presents current clinical use of PET/CT, SPECT/CT, and optical imagingWritten by acknowledged experts. The impact of molecular imaging on diagnostics, therapy, and follow-up in oncology is increasing significantly. The process of molecular imaging includes key biotarget identification, design of specific molecular imaging probes, and their preclinical evaluation, e.g., in vivo using small animal studies. A multitude of such innovative molecular imaging probes have already entered clinical diagnostics in oncology. There is no doubt that in future the emphasis will be on multimodality imaging in which morphological, functional, and molecular imaging techniques are combined in a single clinical investigation that will optimize diagnostic processes. This handbook addresses all aspects of molecular imaging in oncology, ranging from basic research to clinical applications in the era of evidence-based medicine. The first section is devoted to technology and probe design, and examines a variety of PET and SPECT tracers as well as multimodality probes. Preclinical studies are then discussed in detail, with particular attention to multimodality imaging. In the third section, diverse clinical applications are presented, and the book closes by looking at future challenges. This handbook will be of value to all who are interested in the revolution in diagnostic oncology that is being brought about by molecular imaging.
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International Nuclear Information System (INIS)
Schober, Otmar; Riemann, Burkhard
2013-01-01
Considers in detail all aspects of molecular imaging in oncology, ranging from basic research to clinical applications in the era of evidence-based medicine. Examines technological issues and probe design. Discusses preclinical studies in detail, with particular attention to multimodality imaging. Presents current clinical use of PET/CT, SPECT/CT, and optical imagingWritten by acknowledged experts. The impact of molecular imaging on diagnostics, therapy, and follow-up in oncology is increasing significantly. The process of molecular imaging includes key biotarget identification, design of specific molecular imaging probes, and their preclinical evaluation, e.g., in vivo using small animal studies. A multitude of such innovative molecular imaging probes have already entered clinical diagnostics in oncology. There is no doubt that in future the emphasis will be on multimodality imaging in which morphological, functional, and molecular imaging techniques are combined in a single clinical investigation that will optimize diagnostic processes. This handbook addresses all aspects of molecular imaging in oncology, ranging from basic research to clinical applications in the era of evidence-based medicine. The first section is devoted to technology and probe design, and examines a variety of PET and SPECT tracers as well as multimodality probes. Preclinical studies are then discussed in detail, with particular attention to multimodality imaging. In the third section, diverse clinical applications are presented, and the book closes by looking at future challenges. This handbook will be of value to all who are interested in the revolution in diagnostic oncology that is being brought about by molecular imaging.
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2011-02-09
... ENVIRONMENTAL PROTECTION AGENCY [FRL-9264-5] Science Advisory Board Staff Office; Notification of a Public Meeting of the Science Advisory Board Panel for the Review of EPA's Hydraulic Fracturing...-2098 or via e-mail at [email protected] . General information concerning the EPA Science Advisory...
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Global Health in Radiation Oncology
DEFF Research Database (Denmark)
Rodin, Danielle; Yap, Mei Ling; Grover, Surbhi
2017-01-01
programs. However, formalized training and career promotion tracks in global health within radiation oncology have been slow to emerge, thereby limiting the sustained involvement of students and faculty, and restricting opportunities for leadership in this space. We examine here potential structures...... and benefits of formalized global health training in radiation oncology. We explore how defining specific competencies in this area can help trainees and practitioners integrate their activities in global health within their existing roles as clinicians, educators, or scientists. This would also help create...... and funding models might be used to further develop and expand radiation oncology services globally....
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Winkfield, Karen M; Flowers, Christopher R; Patel, Jyoti D; Rodriguez, Gladys; Robinson, Patricia; Agarwal, Amit; Pierce, Lori; Brawley, Otis W; Mitchell, Edith P; Head-Smith, Kimberly T; Wollins, Dana S; Hayes, Daniel F
2017-08-01
In December 2016, the American Society of Clinical Oncology (ASCO) Board of Directors approved the ASCO Strategic Plan to Increase Racial and Ethnic Diversity in the Oncology Workforce. Developed through a multistakeholder effort led by the ASCO Health Disparities Committee, the purpose of the plan is to guide the formal efforts of ASCO in this area over the next three years (2017 to 2020). There are three primary goals: (1) to establish a longitudinal pathway for increasing workforce diversity, (2) to enhance ASCO leadership diversity, and (3) to integrate a focus on diversity across ASCO programs and policies. Improving quality cancer care in the United States requires the recruitment of oncology professionals from diverse backgrounds. The ASCO Strategic Plan to Increase Racial and Ethnic Diversity in the Oncology Workforce is designed to enhance existing programs and create new opportunities that will move us closer to the vision of achieving an oncology workforce that reflects the demographics of the US population it serves.
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76 FR 35226 - National Institute on Drug Abuse; Notice of Closed Meetings
2011-06-16
...-402-6626, [email protected] . (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse... Abuse; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as... invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel...
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77 FR 63846 - National Institute on Drug Abuse; Notice of Closed Meetings
2012-10-17
[email protected] . (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction... Abuse; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis...
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Successful Translation of Fluorescence Navigation During Oncologic Surgery: A Consensus Report.
Rosenthal, Eben L; Warram, Jason M; de Boer, Esther; Basilion, James P; Biel, Merrill A; Bogyo, Matthew; Bouvet, Michael; Brigman, Brian E; Colson, Yolonda L; DeMeester, Steven R; Gurtner, Geoffrey C; Ishizawa, Takeaki; Jacobs, Paula M; Keereweer, Stijn; Liao, Joseph C; Nguyen, Quyen T; Olson, James M; Paulsen, Keith D; Rieves, Dwaine; Sumer, Baran D; Tweedle, Michael F; Vahrmeijer, Alexander L; Weichert, Jamey P; Wilson, Brian C; Zenn, Michael R; Zinn, Kurt R; van Dam, Gooitzen M
2016-01-01
Navigation with fluorescence guidance has emerged in the last decade as a promising strategy to improve the efficacy of oncologic surgery. To achieve routine clinical use, the onus is on the surgical community to objectively assess the value of this technique. This assessment may facilitate both Food and Drug Administration approval of new optical imaging agents and reimbursement for the imaging procedures. It is critical to characterize fluorescence-guided procedural benefits over existing practices and to elucidate both the costs and the safety risks. This report is the result of a meeting of the International Society of Image Guided Surgery (www.isigs.org) on February 6, 2015, in Miami, Florida, and reflects a consensus of the participants' opinions. Our objective was to critically evaluate the imaging platform technology and optical imaging agents and to make recommendations for successful clinical trial development of this highly promising approach in oncologic surgery. © 2016 by the Society of Nuclear Medicine and Molecular Imaging, Inc.
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American Society of Pediatric Hematology/Oncology
... Learn More Explore career opportunities in pediatric hematology/oncology Visit the ASPHO Career Center. Learn More Join ... Privacy Policy » © The American Society of Pediatric Hematology/Oncology
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Smart, Brian A
2009-01-01
The US Food and Drug Administration (FDA) has launched an investigation into the safety of long-acting beta(2)-agonists (LABAs). While the impact of this investigation is yet to be seen, clinicians should be circumspect in the use of these agents and prescribe them according to the recommendations of current asthma guidelines, informing patients and their caretakers about potential risks. As clinical trials attempt to address the question of whether LABAs are safe for use in pediatric and adult populations, current data provide no clear answers. A special hearing of the FDA's Pulmonary-Allergy Drugs Advisory Committee, Drug Safety and Risk Management Advisory Committee, and Pediatric Advisory Committee attempted to seek consensus on the matter as it reviewed the results of controlled clinical trials and conducted a benefit:risk assessment of LABAs to make recommendations on their safety.
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2010-06-14
... a Public Meeting of the Science Advisory Board Exposure and Human Health Committee (EHHC) AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The EPA Science Advisory Board (SAB) Staff... Science Advisory Board can be found on the SAB Web site at http://www.epa.gov/sab . SUPPLEMENTARY...
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[Molecular fundamentals of drug interactions in the therapy of colorectal cancer].
Regulska, Katarzyna; Stanisz, Beata; Regulski, Miłosz; Gieremek, Paulina
2014-03-04
Rapid advances in the field of chemotherapy have resulted in the introduction of numerous antineoplastic drugs into clinical practice, which increased the efficiency of patient management. Also the prevalent use of combination treatment based on drug action synergy contributed to the improved clinical effect associated with cytotoxic drug administration. It seems, however, obvious that the multidirectional pharmacotherapy in oncology requires a thorough knowledge of drugs' pharmaceutical behavior in order to maximize their collective action and prevent the occurrence of unintended drug interactions that could potentially impair treatment effectiveness. In fact, drug interactions constitute a serious problem for current oncology primarily resulting from a narrow therapeutic index specific for the majority of anticancer drugs. This, in turn, indicates that even slight deviations of their pharmacokinetics could cause significant clinical consequences, manifested by alteration of the toxicological profile or reduction of therapeutic efficiency. Hence, the investigation of molecular aspects underlying the mechanisms of various drug interactions seems to be essential for proper and safe patient management. The present article is devoted to the extensive subject of drug interactions occurring in the therapy of colorectal cancer. It presents the available literature data on both positive and negative effects of interactions and it discusses their mechanisms complying with their classification into pharmacokinetic and pharmacodynamic ones.
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2011-07-08
... ENVIRONMENTAL PROTECTION AGENCY [FRL-9431-7] Science Advisory Board Staff Office; Notification of a Public Meeting of the Science Advisory Board Panel for the Review of Great Lakes Restoration... information concerning the EPA Science Advisory Board can be found at the EPA SAB Web site at http://www.epa...
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Pyruvate Dehydrogenase Kinase as a Novel Therapeutic Target in Oncology
Directory of Open Access Journals (Sweden)
Gopinath eSutendra
2013-03-01
Full Text Available Current drug development in oncology is non-selective as it typically focuses on pathways essential for the survival of all dividing cells. The unique metabolic profile of cancer, which is characterized by increased glycolysis and suppressed mitochondrial glucose oxidation provides cancer cells with a proliferative advantage, conducive with apoptosis resistance and even increased angiogenesis. Recent evidence suggests that targeting the cancer-specific metabolic and mitochondrial remodeling may offer selectivity in cancer treatment. Pyruvate dehydrogenase kinase (PDK is a mitochondrial enzyme that is activated in a variety of cancers and results in the selective inhibition of pyruvate dehydrogenase (PDH, a complex of enzymes that converts cytosolic pyruvate to mitochondrial acetyl-CoA, the substrate for the Krebs’ cycle. Inhibition of PDK with either small interfering RNAs or the orphan drug dichloroacetate (DCA shifts the metabolism of cancer cells from glycolysis to glucose oxidation and reverses the suppression of mitochondria-dependent apoptosis. In addition, this therapeutic strategy increases the production of diffusible Krebs’ cycle intermediates and mitochondria-derived reactive oxygen species (mROS, activating p53 or inhibiting pro-proliferative and pro-angiogenic transcription factors like nuclear factor of activated T-cells (NFAT and hypoxia-inducible factor 1α (HIF1α. These effects result in decreased tumor growth and angiogenesis in a variety of cancers with high selectivity. In a small but mechanistic clinical trial in patients with glioblastoma, a highly aggressive and vascular form of brain cancer, DCA decreased tumor angiogenesis and tumor growth, suggesting that metabolic targeting therapies can be translated directly to patients. Therefore, reversing the mitochondrial suppression with metabolic-modulating drugs, like PDK inhibitors holds promise in the rapidly expanding field of metabolic oncology.
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Rosenzweig, Margaret; Giblin, Joan; Mickle, Marsha; Morse, Allison; Sheehy, Patricia; Sommer, Valerie; Bridging The Gap Working Group
2012-03-01
To identify the knowledge and skill needs of oncology nurse practitioners (ONPs) as they enter cancer care practice, and to identify necessary educational resources. Cross-sectional, descriptive. A national e-mail survey. 610 self-described ONPs from the Oncology Nursing Society's database. The project team developed a 28-item electronic survey. The survey was randomly distributed via e-mail. ONPs' feelings of preparedness in the first year of ONP practice. In the first year of practice, 90% of ONPs rated themselves as prepared or very prepared in obtaining patient history, performing physical examination, and documenting findings. ONPs rated themselves as not at all or somewhat prepared in clinical issues of chemotherapy/biotherapy competency (n = 81, 78%), recognizing and managing oncologic emergencies, (n = 77, 70%), and recognizing and managing drug toxicities (n = 63, 61%). The primary source of oncology education for ONPs new to practice was almost exclusively the collaborating or supervising physician (n = 84, 81%). Specific knowledge and skills, such as information about chemotherapy, oncologic emergencies, and side effects of therapy, are needed before an ONP enters a cancer care practice. Cancer-specific education should be made available to new ONPs as they begin independent practice.
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Lee, David Y; Flaherty, Devin C; Lau, Briana J; Deutsch, Gary B; Kirchoff, Daniel D; Huynh, Kelly T; Lee, Ji-Hey; Faries, Mark B; Bilchik, Anton J
2015-11-01
With the first qualifying examination administered September 15, 2014, complex general surgical oncology (CGSO) is now a board-certified specialty. We aimed to assess the attitudes and perceptions of current and future surgical oncology fellows regarding the recently instituted Accreditation Council for Graduate Medical Education (ACGME) accreditation. A 29-question anonymous survey was distributed to fellows in surgical oncology fellowship programs and applicants interviewing at our fellowship program. There were 110 responses (79 fellows and 31 candidates). The response rate for the first- and second-year fellows was 66 %. Ninety-percent of the respondents were aware that completing an ACGME-accredited fellowship leads to board eligibility in CGSO. However, the majority (80 %) of the respondents stated that their decision to specialize in surgical oncology was not influenced by the ACGME accreditation. The fellows in training were concerned about the cost of the exam (90 %) and expressed anxiety in preparing for another board exam (83 %). However, the majority of the respondents believed that CGSO board certification will be helpful (79 %) in obtaining their future career goals. Interestingly, candidate fellows appeared more focused on a career in general complex surgical oncology (p = 0.004), highlighting the impact that fellowship training may have on organ-specific subspecialization. The majority of the surveyed surgical oncology fellows and candidates believe that obtaining board certification in CGSO is important and will help them pursue their career goals. However, the decision to specialize in surgical oncology does not appear to be motivated by ACGME accreditation or the new board certification.
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Comprehensive Oncologic Emergencies Research Network (CONCERN)
The Comprehensive Oncologic Emergencies Research Network (CONCERN) was established in March 2015 with the goal to accelerate knowledge generation, synthesis and translation of oncologic emergency medicine research through multi-center collaborations.
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Information Needs of Hepato-Pancreato-Biliary Surgical Oncology Patients.
Gillespie, Jacqueline; Kacikanis, Anna; Nyhof-Young, Joyce; Gallinger, Steven; Ruthig, Elke
2017-09-01
A marked knowledge gap exists concerning the information needs of hepato-pancreato-biliary (HPB) surgical oncology patients. We investigated the comprehensive information needs of this patient population, including the type and amount of information desired, as well as the preferred method of receiving information. A questionnaire was administered to patients being treated surgically for cancers of the liver, pancreas, gallbladder, or bile ducts at Toronto General Hospital, part of the University Health Network, in Toronto, Canada. The questionnaire examined patients' information needs across six domains of information: medical, practical, physical, emotional, social, and spiritual. Among 36 respondents, the importance of information and amount of information desired differed significantly by domain (both p < 0.001). This group of patients rated information in the medical and physical domains as most important, though they also desired specific items of information from the emotional, practical, and social domains. Patients' overwhelming preference was to receive information via a one-on-one consultation with a healthcare provider. It is important for healthcare providers working with HPB surgical oncology patients to be comprehensive when providing information related to patients' cancer diagnosis, prognosis, associated symptoms, and side effects of treatment. Certain emotional, practical, and social issues (e.g., fears of cancer recurrence, drug coverage options, relationship changes) should be addressed as well. Face-to-face interactions should be the primary mode of delivering information to patients. Our findings are being used to guide the training of healthcare providers and the development of educational resources specific to HPB surgical oncology patients.
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Role of pharmacists in optimizing the use of anticancer drugs in the clinical setting
Directory of Open Access Journals (Sweden)
Ma CSJ
2014-02-01
Full Text Available Carolyn SJ Ma Department of Pharmacy Practice, Daniel K. Inouye College of Pharmacy, University of Hawaii at Hilo, Honolulu, HI, USA Abstract: Oncology pharmacists, also known as oncology pharmacy specialists (OPSs have specialized knowledge of anticancer medications and their role in cancer. As essential member of the interdisciplinary team, OPSs optimize the benefits of drug therapy, help to minimize toxicities and work with patients on supportive care issues. The OPSs expanded role as experts in drug therapy extends to seven major key elements of medication management that include: selection, procurement, storage, preparation/dispensing, prescribing/dosing/transcribing, administration and monitoring/evaluation/education. As front line caregivers in hospital, ambulatory care, long-term care facilities, and community specialty pharmacies, the OPS also helps patients in areas of supportive care including nausea and vomiting, hematologic support, nutrition and infection control. This role helps the patient in the recovery phase between treatment cycles and adherence to chemotherapy treatment schedules essential for optimal treatment and outcome. Keywords: oncology pharmacist, oncology pharmacy specialist, medication management, chemotherapy
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Industry perspectives on market access of innovative drugs
Directory of Open Access Journals (Sweden)
Kim ePauwels
2016-06-01
Full Text Available This study presents industry perspectives on the challenges related to market access of innovative drugs in general and oncology drugs in specific. Fifteen interviews were conducted with representatives of pharmaceutical companies and industry associations. Interviewees call for a broader recognition of value within the assessment and appraisal of drugs. According to interviewees, focus on value is jeopardized by the lack of a common value definition across Europe, poor availability and validity of value measures and cost-saving measures such as external reference price setting and cost-effectiveness analysis at the side of the payers. Centralized assessment of relative-effectiveness at European level would provide a common value estimate across member states, independent of financial drivers. Empirical evidence on patient reported outcomes and societal preferences is however essential in the development of a value definition. Furthermore, value-based pricing would imply a dynamic approach where the price is differentiated across indications and across the lifecycle of the drug, especially in fields such as oncology. Financial drivers however also threat the application of value-based pricing at the side of the industry, making value-based profitability a more appropriate term.
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Handling chemotherapy drugs-Do medical gloves really protect?
Landeck, Lilla; Gonzalez, Ernesto; Koch, Olaf Manfred
2015-10-15
Due to their potential mutagenic, carcinogenic and teratogenic effects occupational exposure to chemotherapy drugs should be kept to a minimum. Utilization of personnel protective devices, especially the use of protective medical gloves, is a mainstay to avoid skin contact. The choice of appropriate gloves is of outstanding importance. For optimal protection in the oncology setting it is essential to establish general guidelines evaluating appropriate materials and defining quality standards. Establishing these guidelines can facilitate better handling and avoid potential hazards and late sequelae. In Europe there are no specific requirements or test methodologies for medical gloves used in the oncology environment. The implementation of uniform standards for gloves used while handling chemotherapy drugs would be desirable. In contrast, in the US medical gloves used to handle chemotherapy drugs have to fulfill requirements according to the ASTM International (American Society of Testing and Materials) standard D 6978-05. Nitrile or natural rubber latex is a preferred basic glove material, while vinyl is considered inappropriate because of its generally increased permeability. For extended exposure to chemotherapy drugs, double gloving, the use of thicker gloves and the frequent change of gloves increases their protective power. © 2014 UICC.
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International Nuclear Information System (INIS)
Harris, Eleanor; Abdel-Wahab, May; Spangler, Ann E.; Lawton, Colleen A.; Amdur, Robert J.
2009-01-01
Purpose: To survey the radiation oncology residency program directors on the topics of departmental and institutional support systems, residency program structure, Accreditation Council for Graduate Medical Education (ACGME) requirements, and challenges as program director. Methods: A survey was developed and distributed by the leadership of the Association of Directors of Radiation Oncology Programs to all radiation oncology program directors. Summary statistics, medians, and ranges were collated from responses. Results: Radiation oncology program directors had implemented all current required aspects of the ACGME Outcome Project into their training curriculum. Didactic curricula were similar across programs nationally, but research requirements and resources varied widely. Program directors responded that implementation of the ACGME Outcome Project and the external review process were among their greatest challenges. Protected time was the top priority for program directors. Conclusions: The Association of Directors of Radiation Oncology Programs recommends that all radiation oncology program directors have protected time and an administrative stipend to support their important administrative and educational role. Departments and institutions should provide adequate and equitable resources to the program directors and residents to meet increasingly demanding training program requirements.
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De Fazio, Pasquale; Cerminara, Gregorio; Ruberto, Stefania; Caroleo, Mariarita; Puca, Maurizio; Rania, Ornella; Suffredini, Elina; Procopio, Leonardo; Segura-Garcìa, Cristina
2017-04-01
Depression and anxiety are common in hospitalized patients. In particular, oncological patients might be vulnerable to depression and anxiety. The aim of this study is to assess and compare different variables and the prevalence of anxiety and depression symptoms between oncological and medically ill inpatients and to identify variables that can influence depressive and anxious symptoms during hospitalization of patients. A total of 360 consecutive hospitalized patients completed the following questionnaires: Hospital Anxiety and Depression Scale (HADS), Patients Health Questionnaire-9, General Health Questionnaire (GHQ-12), 12-Item Short-Form Survey: physical component summary (PCS), and mental component summary (MCS). Patients were divided into oncological patients and non-oncological patients: groups 1 and 2. Only two significant differences were evident between the groups: the PCS of 12-item Short-form Survey was higher in non-oncological patient (p < 0.000), and the GHQ total score was higher in oncological patients. Variables significantly associated with HADS-D ≥ 8 were lower MCS, higher GHQ-12 score, lower PCS, more numerous previous hospitalizations, longer duration of hospitalization, and positive psychiatric family history. Variables significantly associated with HADS-A ≥ 8 were lower MCS, higher GHQ-12 score, positive psychiatric family history, longer duration of hospitalization, and younger age. Anxiety and depression symptoms in concurrent general medical conditions were associated with a specific sociodemographic profile, and this association has implications for clinical care. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.
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Developments in urologic oncology 'OncoForum': The best of 2014.
Gómez-Veiga, F; Alcaraz-Asensio, A; Burgos-Revilla, J; Cózar-Olmo, J
2015-06-01
To review the latest evidence on the oncologic urology of prostate, renal and bladder tumors, analyzing their impact on daily clinical practice and the future medium to long-term regimens. We review the abstracts on prostate, renal and bladder cancer presented at the 2014 congresses (European Association of Urology, American Urological Association, American Society of Clinical Oncology and American Society for Radiation Oncology) that received the best evaluations by the OncoForum committee. The committee considered the following messages important: cytoreductive nephrectomy followed by treatment with a tyrosine-kinase inhibitor can significantly increase the overall survival of patients with metastatic renal cancer; for advanced bladder cancer, early adjuvant chemotherapy after cystectomy is preferable because it significantly increases progression-free survival; and several studies have shown that multiparametric magnetic resonance imaging and fusion imaging improve the diagnosis of prostate cancer and provide greater possibilities for placing patients in the appropriate risk group in order to offer them the best treatment possible. The results of the PREVAIL study have demonstrated the efficacy of enzalutamide on the overall survival of men with castration-resistant prostate cancer and metastases, with no prior chemotherapy. The study also demonstrated the drug's favorable safety profile. Progress is continuing in renal and bladder cancer, improving the approach and clinical results with current therapeutic options. There is constant progress in castration-resistant prostate cancer; in 2014, prechemotherapy treatments were consolidated. Copyright © 2015 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.
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Radiation Oncology in Undergraduate Medical Education: A Literature Review
International Nuclear Information System (INIS)
Dennis, Kristopher E.B.; Duncan, Graeme
2010-01-01
Purpose: To review the published literature pertaining to radiation oncology in undergraduate medical education. Methods and Materials: Ovid MEDLINE, Ovid MEDLINE Daily Update and EMBASE databases were searched for the 11-year period of January 1, 1998, through the last week of March 2009. A medical librarian used an extensive list of indexed subject headings and text words. Results: The search returned 640 article references, but only seven contained significant information pertaining to teaching radiation oncology to medical undergraduates. One article described a comprehensive oncology curriculum including recommended radiation oncology teaching objectives and sample student evaluations, two described integrating radiation oncology teaching into a radiology rotation, two described multidisciplinary anatomy-based courses intended to reinforce principles of tumor biology and radiotherapy planning, one described an exercise designed to test clinical reasoning skills within radiation oncology cases, and one described a Web-based curriculum involving oncologic physics. Conclusions: To the authors' knowledge, this is the first review of the literature pertaining to teaching radiation oncology to medical undergraduates, and it demonstrates the paucity of published work in this area of medical education. Teaching radiation oncology should begin early in the undergraduate process, should be mandatory for all students, and should impart knowledge relevant to future general practitioners rather than detailed information relevant only to oncologists. Educators should make use of available model curricula and should integrate radiation oncology teaching into existing curricula or construct stand-alone oncology rotations where the principles of radiation oncology can be conveyed. Assessments of student knowledge and curriculum effectiveness are critical.
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Kubota, Yosuke; Okuyama, Toru; Uchida, Megumi; Umezawa, Shino; Nakaguchi, Tomohiro; Sugano, Koji; Ito, Yoshinori; Katsuki, Fujika; Nakano, Yumi; Nishiyama, Takeshi; Katayama, Yoshiko; Akechi, Tatsuo
2016-06-01
Oncology nurses are expected to play an important role in psychosocial care for cancer patients. The aim of this study was to examine whether a novel training program aimed at enhancing oncology nurses' ability to assess and manage common psychological problems in cancer patients would improve participants' self-reported confidence, knowledge, and attitudes regarding care of patients with common psychological problems (trial register: UMIN000008559). Oncology nurses were assigned randomly to either the intervention group (N = 50) or the waiting list control group (N = 46). The intervention group received a 16-h program, the content of which focused on four psychological issues: normal reactions, clinically significant distress, suicidal thoughts, and delirium. Each session included a role-play exercise, group work, and didactic lecture regarding assessment and management of each problem. Primary outcomes were changes in self-reported confidence, knowledge, and attitudes toward the common psychological problems between pre-intervention and 3 months post-intervention. Secondary outcomes were job-related stress and burnout. Intervention acceptability to participants was also assessed. In the intervention group, confidence and knowledge but not attitudes were significantly improved relative to the control group. No significant intervention effects were found for job- related stress and burnout. A high percentage (98%) of participants considered the program useful in clinical practice. This psycho-oncology training program improved oncology nurses' confidence and knowledge regarding care for patients with psychological problems. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.
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ITS Standards Advisory : Dynamic Message Signs (DMS)
2003-01-01
ITS Standards Advisories provide the transportation community with information and guidance on key activities related to ITS standards, with each Advisory focusing on a single ITS application and its corresponding standards. This advisory focuses on ...
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75 FR 17701 - High Energy Physics Advisory Panel
2010-04-07
... DEPARTMENT OF ENERGY High Energy Physics Advisory Panel AGENCY: Department of Energy, Office of... Physics Advisory Panel (HEPAP). Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires... Energy Physics Advisory Panel; U.S. Department of Energy; SC-25/ Germantown Building, 1000 Independence...
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Oncology nursing in Cuba: report of the delegation.
Sheldon, Lisa Kennedy; Leonard, Kathleen; Gross, Anne; Hartnett, Erin; Poage, Ellen; Squires, Jennifer; Ullemeyer, Vicki; Schueller, Mary; Stary, Susan; Miller, Mary Alice
2012-08-01
In December 2011, the first delegation of oncology nurses from the United States visited Havana, Cuba. The delegation included oncology nurses, educators, and leaders from across America and provided opportunities to learn about the healthcare system, cancer, and oncology nursing in Cuba. Delegation members attended lectures, toured facilities, and enjoyed Cuban culture. This exchange highlighted the similarities in cancer care and oncology nursing between countries and opened doors for future collaborations.
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2012-09-11
... Committee; Earth Science Subcommittee; Applied Sciences Advisory Group Meeting AGENCY: National Aeronautics... the Applied Science Advisory Group. This Subcommittee reports to the Earth Science Subcommittee... following topics: --Applied Sciences Program Update --Earth Science Data Latency Study Preliminary Update...
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Molecular fundamentals of drug interactions in the therapy of colorectal cancer
Directory of Open Access Journals (Sweden)
Katarzyna Regulska
2014-03-01
Full Text Available Rapid advances in the field of chemotherapy have resulted in the introduction of numerous antineoplastic drugs into clinical practice, which increased the efficiency of patient management. Also the prevalent use of combination treatment based on drug action synergy contributed to the improved clinical effect associated with cytotoxic drug administration. It seems, however, obvious that the multidirectional pharmacotherapy in oncology requires a thorough knowledge of drugs’ pharmaceutical behavior in order to maximize their collective action and prevent the occurrence of unintended drug interactions that could potentially impair treatment effectiveness. In fact, drug interactions constitute a serious problem for current oncology primarily resulting from a narrow therapeutic index specific for the majority of anticancer drugs. This, in turn, indicates that even slight deviations of their pharmacokinetics could cause significant clinical consequences, manifested by alteration of the toxicological profile or reduction of therapeutic efficiency. Hence, the investigation of molecular aspects underlying the mechanisms of various drug interactions seems to be essential for proper and safe patient management. The present article is devoted to the extensive subject of drug interactions occurring in the therapy of colorectal cancer. It presents the available literature data on both positive and negative effects of interactions and it discusses their mechanisms complying with their classification into pharmacokinetic and pharmacodynamic ones.
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Surgical Oncology Nursing: Looking Back, Looking Forward.
Crane, Patrick C; Selanders, Louise
2017-02-01
To provide a historical perspective in the development of oncology nursing and surgical oncology as critical components of today's health care system. Review of the literature and Web sites of key organizations. The evolution of surgical oncology nursing has traversed a historical journey from that of a niche subspecialty of nursing that had very little scientific underpinning, to a highly sophisticated discipline within a very short time. Nursing continues to contribute its expertise to the encyclopedic knowledge base of surgical oncology and cancer care, which have helped improve the lives of countless patients and families who have had to face the difficulties of this diagnosis. An understanding of the historical context for which a nursing specialty such as surgical oncology nursing evolves is critical to gaining an appreciation for the contributions of nursing. Copyright © 2016 Elsevier Inc. All rights reserved.
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The context of oncology nursing practice: an integrative review.
Bakker, Debra; Strickland, Judith; Macdonald, Catherine; Butler, Lorna; Fitch, Margaret; Olson, Karin; Cummings, Greta
2013-01-01
In oncology, where the number of patients is increasing, there is a need to sustain a quality oncology nursing workforce. Knowledge of the context of oncology nursing can provide information about how to create practice environments that will attract and retain specialized oncology nurses. The aims of this review were to determine the extent and quality of the literature about the context of oncology nursing, explicate how "context" has been described as the environment where oncology nursing takes place, and delineate forces that shape the oncology practice environment. The integrative review involved identifying the problem, conducting a structured literature search, appraising the quality of data, extracting and analyzing data, and synthesizing and presenting the findings. Themes identified from 29 articles reflected the surroundings or background (structural environment, world of cancer care), and the conditions and circumstances (organizational climate, nature of oncology nurses' work, and interactions and relationships) of oncology nursing practice settings. The context of oncology nursing was similar yet different from other nursing contexts. The uniqueness was attributed to the dynamic and complex world of cancer control and the personal growth that is gained from the intense therapeutic relationships established with cancer patients and their families. The context of healthcare practice has been linked with patient, professional, or system outcomes. To achieve quality cancer care, decision makers need to understand the contextual features and forces that can be modified to improve the oncology work environment for nurses, other providers, and patients.
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Cancer Patients and Oncology Nursing: Perspectives of Oncology ...
African Journals Online (AJOL)
2017-10-26
Oct 26, 2017 ... findings of this study, nurses declared that working with cancer patients increase burnout, they are ..... of working in oncology to entire work life was 75.8% for nurses in the study .... This professional balance is important for ...
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76 FR 4928 - National Institute on Drug Abuse; Amended Notice of Meeting
2011-01-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Advisory Council on Drug Abuse, February 2, 2011, 8:30 a.m. to 2:45 p.m., National Institutes of Health...
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Observation and Analysis of Anti-cancer Drug Use and Dose ...
African Journals Online (AJOL)
As all anti-cancer drugs are of narrow therapeutic window so dose individualization is required to be done. A study was conducted to check the use of anti-cancer drugs in the local anti-cancer facility of Bahawalpur i.e. Bahawalpur Institute of Nuclear Medicine and Oncology (BINO). In this study, the dose individualization ...
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Robot-assisted surgery in gynecological oncology
DEFF Research Database (Denmark)
Kristensen, Steffen E; Mosgaard, Berit J; Rosendahl, Mikkel
2017-01-01
INTRODUCTION: Robot-assisted surgery has become more widespread in gynecological oncology. The purpose of this systematic review is to present current knowledge on robot-assisted surgery, and to clarify and discuss controversies that have arisen alongside the development and deployment. MATERIAL...... was performed by screening of titles and abstracts, and by full text scrutiny. From 2001 to 2016, a total of 76 references were included. RESULTS: Robot-assisted surgery in gynecological oncology has increased, and current knowledge supports that the oncological safety is similar, compared with previous...
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Beach Advisory and Closing Online Notification (BEACON) system
Beach Advisory and Closing Online Notification system (BEACON) is a colletion of state and local data reported to EPA about beach closings and advisories. BEACON is the public-facing query of the Program tracking, Beach Advisories, Water quality standards, and Nutrients database (PRAWN) which tracks beach closing and advisory information.
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IMPACT web portal: oncology database integrating molecular profiles with actionable therapeutics.
Hintzsche, Jennifer D; Yoo, Minjae; Kim, Jihye; Amato, Carol M; Robinson, William A; Tan, Aik Choon
2018-04-20
With the advancement of next generation sequencing technology, researchers are now able to identify important variants and structural changes in DNA and RNA in cancer patient samples. With this information, we can now correlate specific variants and/or structural changes with actionable therapeutics known to inhibit these variants. We introduce the creation of the IMPACT Web Portal, a new online resource that connects molecular profiles of tumors to approved drugs, investigational therapeutics and pharmacogenetics associated drugs. IMPACT Web Portal contains a total of 776 drugs connected to 1326 target genes and 435 target variants, fusion, and copy number alterations. The online IMPACT Web Portal allows users to search for various genetic alterations and connects them to three levels of actionable therapeutics. The results are categorized into 3 levels: Level 1 contains approved drugs separated into two groups; Level 1A contains approved drugs with variant specific information while Level 1B contains approved drugs with gene level information. Level 2 contains drugs currently in oncology clinical trials. Level 3 provides pharmacogenetic associations between approved drugs and genes. IMPACT Web Portal allows for sequencing data to be linked to actionable therapeutics for translational and drug repurposing research. The IMPACT Web Portal online resource allows users to query genes and variants to approved and investigational drugs. We envision that this resource will be a valuable database for personalized medicine and drug repurposing. IMPACT Web Portal is freely available for non-commercial use at http://tanlab.ucdenver.edu/IMPACT .
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76 FR 21877 - Environmental Management Advisory Board
2011-04-19
... DEPARTMENT OF ENERGY Environmental Management Advisory Board AGENCY: Department of Energy. ACTION: Notice of call for nominations for appointment to the Environmental Management Advisory Board. SUMMARY... Environmental Management Advisory Board. DATES: Nominations will be accepted through May 13, 2011. ADDRESSES...
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77 FR 19300 - National Infrastructure Advisory Council
2012-03-30
... DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS-2012-0012] National Infrastructure Advisory... an open Federal Advisory Committee meeting. SUMMARY: The National Infrastructure Advisory Council... business. For additional information, please consult the NIAC Web site, www.dhs.gov/NIAC , or contact the...
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2013-03-18
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...
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2012-04-05
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...
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2011-03-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...
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2011-10-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of... Administration (FDA) is postponing the meeting of the General and Plastic Surgery Devices Panel of the Medical...
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2011-10-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...
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2010-08-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...
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2013-05-23
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...
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2011-07-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0478] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...
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Psycho-oncology in Korea: past, present and future.
Lee, Hyun Jeong; Lee, Kwang-Min; Jung, Dooyoung; Shim, Eun-Jung; Hahm, Bong-Jin; Kim, Jong-Heun
2017-01-01
Psycho-oncology in Korea was introduced among the circle of consultation-liaison psychiatrists, in the 1990s. For almost 25 years, the field has been developing at a steady pace as the psychosocial needs of patients with cancer continue to increase. In this study, we review the history of psycho-oncology in Korea, in a chronological order, within the domains of clinical practice, research activity, training, and public policy. Before the 1990s, patients with cancer with psychiatric comorbidities were usually taken care of by consultation-liaison psychiatrists in general hospitals. In 1993, psycho-oncology was first introduced by psychiatrists. Psychologists, nurses, and social workers have also been increasingly involved in providing psychosocial care for patients with cancer. Professionals from various disciplines began to communicate, and agreed to found the Korean Psycho-Oncology Study Group (KPOSG) in 2006, the first academic society in this field. In 2009, National Cancer Center published the "Recommendations for Distress Management in Patients with Cancer", which are consensus-based guidelines for Korean patients. In 2014, the KPOSG was dissolved and absorbed into a new organization, the Korean Psycho-Oncology Society (KPOS). It functions as a center of development of psycho-oncology, publishing official journals, and hosting annual conferences. There are many challenges, including, low awareness of psycho-oncology, presence of undertreated psychiatric disorders in patients with cancer, shortage of well-trained psycho-oncologists, stigma, and suicide risk. It is important to improve the cancer care system to the extent that psycho-oncology is integrated with mainstream oncology. Considering the socio-cultural characteristics of Korean cancer care, a Korean model of distress management is being prepared by the KPOS. This article provides an overview of the development, current issues, and future challenges of psycho-oncology in Korea. Through its long journey
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Proteomics of anti-cancer drugs
Czech Academy of Sciences Publication Activity Database
Kovářová, Hana; Martinková, Jiřina; Hrabáková, Rita; Skalníková, Helena; Novák, Petr; Hajdůch, M.; Gadher, S. J.
2009-01-01
Roč. 276, Supplement 1 (2009), s. 84-84 E-ISSN 1742-4658. [34th FEBS Congress. 04.07.2009-09.07.2009, Praha] R&D Projects: GA MŠk LC07017 Institutional research plan: CEZ:AV0Z50450515; CEZ:AV0Z50200510 Keywords : proteomics * anti-cancer drugs * biomarkers Subject RIV: FD - Oncology ; Hematology
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Pharmacovigilance in oncology: evaluation of current practice and future perspectives.
Baldo, Paolo; De Paoli, Paolo
2014-10-01
Pharmacovigilance (PV), or drug safety monitoring, aims to improve patient safety through the detection and management of drug-related adverse reactions. It is implemented both by spontaneous reporting of adverse drug reactions (ADRs) and by careful detection of signals suggestive of drug toxicity. PV is an important clinical topic in clinical practice and pharmacotherapy, assuring the maintenance of a safe risk/benefit ratio throughout the commercial life cycle of a drug. We conducted a structured literature search on PubMed, Scopus, Cinahl and the Cochrane Library. We also performed manual searches in international databases of ADR individual reports to outline a structured profile on the topic. Our goal was to review key elements that affect safety monitoring of cancer drugs and their appropriate use, highlighting the strengths and weaknesses of PV in oncology. This paper provides an understanding of the methodologies used by PV in current clinical practice and particularly in cancer drug therapy; a focus upon reporting of ADRs by health professionals and patients; and a focus upon methods used by PV to detect new signals of risk/harm related to medicines utilization. To our knowledge, few articles focus upon the importance of PV and post-marketing surveillance of cancer drug therapies. Structured management of spontaneous reports of ADRs and data collection is essential to monitoring the safe use of drugs in this field in which pharmacotherapy is affected by high incidence of drug-related complications and by a narrow benefit/risk ratio. © 2014 John Wiley & Sons, Ltd.
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2011-03-09
....gov . Submit written comments to the Division of Dockets Management, Food and Drug Administration... be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday... telephone number is 301- 589-5200. Contact Person: Diem-Kieu Ngo, Center for Drug Evaluation and Research...
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A Nationwide Medical Student Assessment of Oncology Education.
Mattes, Malcolm D; Patel, Krishnan R; Burt, Lindsay M; Hirsch, Ariel E
2016-12-01
Cancer is the second leading cause of death in the USA, but there is minimal data on how oncology is taught to medical students. The purpose of this study is to characterize oncology education at US medical schools. An electronic survey was sent between December 2014 and February 2015 to a convenience sample of medical students who either attended the American Society for Radiation Oncology annual meeting or serve as delegates to the American Association of Medical Colleges. Information on various aspects of oncology instruction at participants' medical schools was collected. Seventy-six responses from students in 28 states were received. Among the six most common causes of death in the USA, cancer reportedly received the fourth most curricular time. During the first, second, and third years of medical school, participants most commonly reported 6-10, 16-20, and 6-10 h of oncology teaching, respectively. Participants were less confident in their understanding of cancer treatment than workup/diagnosis or basic science/natural history of cancer (p oncology-oriented clerkship. During each mandatory rotation, Oncology education is often underemphasized and fragmented with wide variability in content and structure between medical schools, suggesting a need for reform.
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[Application of three-dimensional computer graphics in oncology].
Joyeux, H; Jaeger, M; Briand, D; Servois, V; Masson, B; Borianne, P; de Reffye, P
1996-01-01
Accurate 3D tumoral volume evaluation is now possible through the combined use and progress of computer graphics technics (3D reconstruction and visualization) and medical imagery (helicoidal TDM scanner). Specific organ and pathology oriented softwares can help answer rapidly to problems posed by oncologic praticians. A new decision support for diagnosis, therapy and follow-up is emerging. First results in liver tumors and hepatic regeneration macroscopic biometrics are presented. Tumoral or organ volumic index will be usable in the follow-up. TNM staging, external conformal radiotherapy for prostatic or brain tumors, drugs cytolytic effects evaluation will take great advantage of these technologies. 3D visualization and matching CT and MRI imagery can help computed assisted surgery.
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2012-03-02
... for the implementation of best business practices to improve Federal Government management and... performance management, Senior Executive Service (SES) leadership development and SES performance appraisal... President's Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting AGENCY...
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2010-01-11
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0606] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice...) is announcing an amendment to the notice of a meeting of the General and Plastic Surgery Devices...
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78 FR 40487 - National Infrastructure Advisory Council
2013-07-05
... DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS-2013-0033] National Infrastructure Advisory... an open Federal Advisory Committee Meeting. SUMMARY: The National Infrastructure Advisory Council..., from 1:30 p.m. to 4:30 p.m. The meeting may close early if the committee has completed its business...
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Encyclopedia of radiation oncology
Energy Technology Data Exchange (ETDEWEB)
Brady, Luther W. [Drexel Univ. College of Medicine, Philadelphia, PA (United States); Yaeger, Theodore E. (eds.) [Wake Forest Univ. School of Medicine, Winston-Salem, NC (United States). Dept. of Radiation Oncology
2013-02-01
The simple A to Z format provides easy access to relevant information in the field of radiation oncology. Extensive cross references between keywords and related articles enable efficient searches in a user-friendly manner. Fully searchable and hyperlinked electronic online edition. The aim of this comprehensive encyclopedia is to provide detailed information on radiation oncology. The wide range of entries are written by leading experts. They will provide basic and clinical scientists in academia, practice and industry with valuable information about the field of radiation oncology. Those in related fields, students, teachers, and interested laypeople will also benefit from the important and relevant information on the most recent developments. Please note that this publication is available as print only or online only or print + online set. Save 75% of the online list price when purchasing the bundle. For more information on the online version please type the publication title into the search box above, then click on the eReference version in the results list.
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2012-06-26
... for the implementation of best business practices to improve Federal Government management and... management, IT vendor performance management, Senior Executive Service (SES) leadership development and SES... President's Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting AGENCY...
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The Evolution of Gero-Oncology Nursing.
Bond, Stewart M; Bryant, Ashley Leak; Puts, Martine
2016-02-01
This article summarizes the evolution of gero-oncology nursing and highlights key educational initiatives, clinical practice issues, and research areas to enhance care of older adults with cancer. Peer-reviewed literature, position statements, clinical practice guidelines, Web-based materials, and professional organizations' resources. Globally, the older adult cancer population is rapidly growing. The care of older adults with cancer requires an understanding of their diverse needs and the intersection of cancer and aging. Despite efforts to enhance competence in gero-oncology and to develop a body of evidence, nurses and health care systems remain under-prepared to provide high-quality care for older adults with cancer. Nurses must take a leadership role in integrating gerontological principles into oncology settings. Working closely with interdisciplinary team members, nurses should utilize available resources and continue to build evidence through gero-oncology nursing research. Copyright © 2016 Elsevier Inc. All rights reserved.
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Current management of surgical oncologic emergencies.
Directory of Open Access Journals (Sweden)
Marianne R F Bosscher
Full Text Available For some oncologic emergencies, surgical interventions are necessary for dissolution or temporary relieve. In the absence of guidelines, the most optimal method for decision making would be in a multidisciplinary cancer conference (MCC. In an acute setting, the opportunity for multidisciplinary discussion is often not available. In this study, the management and short term outcome of patients after surgical oncologic emergency consultation was analyzed.A prospective registration and follow up of adult patients with surgical oncologic emergencies between 01-11-2013 and 30-04-2014. The follow up period was 30 days.In total, 207 patients with surgical oncologic emergencies were included. Postoperative wound infections, malignant obstruction, and clinical deterioration due to progressive disease were the most frequent conditions for surgical oncologic emergency consultation. During the follow up period, 40% of patients underwent surgery. The median number of involved medical specialties was two. Only 30% of all patients were discussed in a MCC within 30 days after emergency consultation, and only 41% of the patients who underwent surgery were discussed in a MCC. For 79% of these patients, the surgical procedure was performed before the MCC. Mortality within 30 days was 13%.In most cases, surgery occurred without discussing the patient in a MCC, regardless of the fact that multiple medical specialties were involved in the treatment process. There is a need for prognostic aids and acute oncology pathways with structural multidisciplinary management. These will provide in faster institution of the most appropriate personalized cancer care, and prevent unnecessary investigations or invasive therapy.
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Current management of surgical oncologic emergencies.
Bosscher, Marianne R F; van Leeuwen, Barbara L; Hoekstra, Harald J
2015-01-01
For some oncologic emergencies, surgical interventions are necessary for dissolution or temporary relieve. In the absence of guidelines, the most optimal method for decision making would be in a multidisciplinary cancer conference (MCC). In an acute setting, the opportunity for multidisciplinary discussion is often not available. In this study, the management and short term outcome of patients after surgical oncologic emergency consultation was analyzed. A prospective registration and follow up of adult patients with surgical oncologic emergencies between 01-11-2013 and 30-04-2014. The follow up period was 30 days. In total, 207 patients with surgical oncologic emergencies were included. Postoperative wound infections, malignant obstruction, and clinical deterioration due to progressive disease were the most frequent conditions for surgical oncologic emergency consultation. During the follow up period, 40% of patients underwent surgery. The median number of involved medical specialties was two. Only 30% of all patients were discussed in a MCC within 30 days after emergency consultation, and only 41% of the patients who underwent surgery were discussed in a MCC. For 79% of these patients, the surgical procedure was performed before the MCC. Mortality within 30 days was 13%. In most cases, surgery occurred without discussing the patient in a MCC, regardless of the fact that multiple medical specialties were involved in the treatment process. There is a need for prognostic aids and acute oncology pathways with structural multidisciplinary management. These will provide in faster institution of the most appropriate personalized cancer care, and prevent unnecessary investigations or invasive therapy.
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2011-10-17
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-095)] NASA Advisory Committee; Renewal of NASA's International Space Station Advisory Committee Charter AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of renewal and amendment of the Charter of the International...
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McFarland, Daniel C; Holland, Jimmie; Holcombe, Randall F
2015-07-01
The demand for hematologists and oncologists is not being met. We hypothesized that an inpatient hematology-oncology ward rotation would increase residents' interest. Potential reasons mitigating interest were explored and included differences in physician distress, empathy, resilience, and patient death experiences. Agreement with the statement "I am interested in pursuing a career/fellowship in hematology and oncology" was rated by residents before and after a hematology-oncology rotation, with 0 = not true at all, 1 = rarely true, 2 = sometimes true, 3 = often true, and 4 = true nearly all the time. House staff rotating on a hematology-oncology service from November 2013 to October 2014 also received questionnaires before and after their rotations containing the Connors-Davidson Resilience Scale, the Impact of Events Scale-Revised, the Interpersonal Reactivity Index, demographic information, and number of dying patients cared for and if a sense of meaning was derived from that experience. Fifty-six residents completed both before- and after-rotation questionnaires (response rate, 58%). The mean interest score was 1.43 initially and decreased to 1.24 after the rotation (P = .301). Female residents' mean score was 1.13 initially and dropped to 0.81 after the rotation (P = .04). Male residents' mean score was 1.71 initially and 1.81 after the rotation (P = .65). Decreased hematology-oncology interest correlated with decreased empathy; male interest decrease correlated with decreased resilience. An inpatient hematology-oncology ward rotation does not lead to increased interest and, for some residents, may lead to decreased interest in the field. Encouraging outpatient hematology-oncology rotations and the cultivation of resilience, empathy, and meaning regarding death experiences may increase resident interest. Copyright © 2015 by American Society of Clinical Oncology.
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2012-01-19
... Business Enterprise: Meeting of the National Advisory Council on Minority Business Enterprise AGENCY.... SUMMARY: The National Advisory Council for Minority Business Enterprise (NACMBE) will hold its fifth... deliberate on possible recommendations. The Subcommittee topics include: (1) Definition of Minority Business...
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Wong, Carlos King Ho; Wu, Olivia; Cheung, Bernard M Y
2018-02-01
The aim of this article is to describe the process, evaluation criteria, and possible outcomes of decision-making for new drugs listed in the Hong Kong Hospital Authority Drug Formulary in comparison to the health technology assessment (HTA) policy overseas. Details of decision-making processes including the new drug listing submission, Drug Advisory Committee (DAC) meeting, and procedures prior to and following the meeting, were extracted from the official Hong Kong Hospital Authority drug formulary management website and manual. Publicly-available information related to the new drug decision-making process for five HTA agencies [the National Institute of Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), the Australia Pharmaceutical Benefits Advisory Committee (PBAC), the Canadian Agency for Drugs and Technologies in Health (CADTH), and the New Zealand Pharmaceutical Management Agency (PHARMAC)] were reviewed and retrieved from official documents from public domains. The DAC is in charge of systemically and critically appraising new drugs before they are listed on the formulary, reviewing submitted applications, and making the decision to list the drug based on scientific evidence to which safety, efficacy, and cost-effectiveness are the primary considerations. When compared with other HTA agencies, transparency of the decision-making process of the DAC, the relevance of clinical and health economic evidence, and the lack of health economic and methodological input of submissions are the major challenges to the new-drug listing policy in Hong Kong. Despite these challenges, this review provides suggestions for the establishment of a more transparent, credible, and evidence-based decision-making process in the Hong Kong Hospital Authority Drug Formulary. Proposals for improvement in the listing of new drugs in the formulary should be a priority of healthcare reforms.
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Quality Assessment in Oncology
International Nuclear Information System (INIS)
Albert, Jeffrey M.; Das, Prajnan
2012-01-01
The movement to improve healthcare quality has led to a need for carefully designed quality indicators that accurately reflect the quality of care. Many different measures have been proposed and continue to be developed by governmental agencies and accrediting bodies. However, given the inherent differences in the delivery of care among medical specialties, the same indicators will not be valid across all of them. Specifically, oncology is a field in which it can be difficult to develop quality indicators, because the effectiveness of an oncologic intervention is often not immediately apparent, and the multidisciplinary nature of the field necessarily involves many different specialties. Existing and emerging comparative effectiveness data are helping to guide evidence-based practice, and the increasing availability of these data provides the opportunity to identify key structure and process measures that predict for quality outcomes. The increasing emphasis on quality and efficiency will continue to compel the medical profession to identify appropriate quality measures to facilitate quality improvement efforts and to guide accreditation, credentialing, and reimbursement. Given the wide-reaching implications of quality metrics, it is essential that they be developed and implemented with scientific rigor. The aims of the present report were to review the current state of quality assessment in oncology, identify existing indicators with the best evidence to support their implementation, and propose a framework for identifying and refining measures most indicative of true quality in oncologic care.
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Quality Assessment in Oncology
Energy Technology Data Exchange (ETDEWEB)
Albert, Jeffrey M. [Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Das, Prajnan, E-mail: prajdas@mdanderson.org [Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas (United States)
2012-07-01
The movement to improve healthcare quality has led to a need for carefully designed quality indicators that accurately reflect the quality of care. Many different measures have been proposed and continue to be developed by governmental agencies and accrediting bodies. However, given the inherent differences in the delivery of care among medical specialties, the same indicators will not be valid across all of them. Specifically, oncology is a field in which it can be difficult to develop quality indicators, because the effectiveness of an oncologic intervention is often not immediately apparent, and the multidisciplinary nature of the field necessarily involves many different specialties. Existing and emerging comparative effectiveness data are helping to guide evidence-based practice, and the increasing availability of these data provides the opportunity to identify key structure and process measures that predict for quality outcomes. The increasing emphasis on quality and efficiency will continue to compel the medical profession to identify appropriate quality measures to facilitate quality improvement efforts and to guide accreditation, credentialing, and reimbursement. Given the wide-reaching implications of quality metrics, it is essential that they be developed and implemented with scientific rigor. The aims of the present report were to review the current state of quality assessment in oncology, identify existing indicators with the best evidence to support their implementation, and propose a framework for identifying and refining measures most indicative of true quality in oncologic care.
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Recent developments of dual-energy CT in oncology
Energy Technology Data Exchange (ETDEWEB)
Simons, David; Schlemmer, Heinz-Peter [Department of Radiology, German Cancer Research Center (DKFZ), Heidelberg (Germany); Kachelriess, Marc [Department of Medical Physics in Radiology, Division of X-ray Imaging and CT, German Cancer Research Center (DKFZ), Heidelberg (Germany)
2014-04-15
Dual-energy computed tomography (DECT) can amply contribute to support oncological imaging: the DECT technique offers promising clinical applications in oncological imaging for tumour detection and characterisation while concurrently reducing the radiation dose. Fast image acquisition at two different X-ray energies enables the determination of tissue- or material-specific features, the calculation of virtual unenhanced images and the quantification of contrast medium uptake; thus, tissue can be characterised and subsequently monitored for any changes during treatment. DECT is already widely used, but its potential in the context of oncological imaging has not been fully exploited yet. The technology is the subject of ongoing innovation and increasingly with respect to its clinical potential, particularly in oncology. This review highlights recent state-of-the-art DECT techniques with a strong emphasis on ongoing DECT developments relevant to oncologic imaging, and then focuses on clinical DECT applications, especially its prospective uses in areas of oncological imaging. circle Dual-energy CT (DECT) offers fast, robust, quantitative and functional whole-body imaging. (orig.)
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Valentini, V; Glimelius, B; Frascino, V
2013-09-01
The past two decades have brought tremendous changes to the practice of radiation oncology and medical oncology. To manage all the complexities related to the new technologies and the new drugs, the radiation and medical oncologists have to enhance their clinical action and professional skill profile. To accomplish this they have to find reliable tools in the quality of their medical practice and in future research activities. Quality assurance (QA) and quality control (QC) for radiation and medical oncologists mean to clarify the different components of the clinical decision, to supervise with proper methodology the required steps needed to accomplish the agreed outcomes and to control them. Quality for radiation and medical oncology means to supervise each clinical and technical component of the whole process to guarantee that all steps together will arrive at the final and best possible outcome. Key components are guidelines, specialization and a multidisciplinary approach. The research of global quality could represent a further complexity, but it is the best tool to give a perspective and a chance to further improvements of our disciplines and to promote better outcome in all cancer patients. Copyright © 2013 Elsevier Ltd. All rights reserved.
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Directory of Open Access Journals (Sweden)
Hesty U. Ramadaniati
2016-03-01
Full Text Available Paediatric patients with cancer are a high-risk patient population for medication misadventures. This study aimed to document and evaluate the role of pharmacists’ interventions during dispensing-related activities in minimising the occurrence of medication misadventure in haematology-oncology patients. The primary investigator observed and documented all clinical interventions during dispensing-related activities performed by clinical pharmacists in a haematology-oncology pharmacy during 33-day. A total of 359 interventions were performed for 1028 patients. The rates of intervention were 20.04 per 100 medication orders and 34.92 per 100 patients. Provision of drug information was the most common interventions constituting more than three quarters of all interventions. According to therapeutic groups, cytotoxic antineoplastics made up more than half of all interventions. Of all interventions, 22 involved recommendations leading to changes in patients’ treatment (active interventions, and all recommendations were accepted. The top three medication errors were due to inappropriate dosing, labelling error, and unfulfilled indication. Clinical pharmacists’ intervention during dispensing in a paediatric haematology-oncology pharmacy improved medication safety and patient care by minimising the incidence of medication misadventures.
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[Interactions of cytostatic agents with other drugs].
Sauter, C
1991-08-31
With the degree of polypharmacy currently practiced in the field of oncology, there are undoubtedly many drug interactions. In the present study the influence of "non-cytotoxic" drugs on anticancer drugs is discussed, but not the reverse. Not only is the augmentation (reversal of multidrug resistance) or the reduction of antitumor properties of cytotoxic drugs observed, but also cytostatic activities of "non-cytotoxic" drugs themselves. Examples are calmodulin inhibitors such as phenothiazines and tricyclic antidepressants. Interactions may also increase side effects of cytostatic drugs or even neutralize the antitumoral activity. To ensure that interactions are not overlooked, all medicaments being administered should be listed. It is, however, not feasible yet to determine serum concentrations of all the drugs given to the patient. The antitumor activity of supportive care could be evaluated in randomized studies (e.g. cytostatic drugs +/- antidepressants).
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42 CFR 90.9 - Public health advisory.
2010-10-01
... 42 Public Health 1 2010-10-01 2010-10-01 false Public health advisory. 90.9 Section 90.9 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES HEALTH ASSESSMENTS AND HEALTH... PROCEDURES § 90.9 Public health advisory. ATSDR may issue a public health advisory based on the findings of a...
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Omics-based nanomedicine: the future of personalized oncology.
Rosenblum, Daniel; Peer, Dan
2014-09-28
The traditional "one treatment fits all" paradigm disregards the heterogeneity between cancer patients, and within a particular tumor, thus limit the success of common treatments. Moreover, current treatment lacks specificity and therefore most of the anticancer drugs induce severe adverse effects. Personalized medicine aims to individualize therapeutic interventions, based on the growing knowledge of the human multiple '-oms' (e.g. genome, epigenome, transcriptome, proteome and metabolome), which has led to the discovery of various biomarkers that can be used to detect early stage cancers and predict tumor progression, drug response, and clinical outcome. Nanomedicine, the application of nanotechnology to healthcare, holds great promise for revolutionizing disease management such as drug delivery, molecular imaging, reduced adverse effects and the ability to contain both therapeutic and diagnostic modalities simultaneously termed theranostics. Personalizednanomedicine has the power of combining nanomedicine with clinical and molecular biomarkers ("OMICS" data) achieving improve prognosis and disease management as well as individualized drug selection and dosage profiling to ensure maximal efficacy and safety. Tumor's heterogeneity sets a countless challenge for future personalized therapy in cancer, however the use of multi-parameter 'omic's data for specific molecular biomarkers recognition together with versatile drug delivery nanocarriers, which could target concomitantly and specifically tumor cells subpopulations, might heralds a brighter future for personalized cancer management. In this review, we present the current leading technologies available for personalized oncology. We discusses the immense potential of combining the best of these two worlds, nanomedicine and high throughput OMICS technologies to pave the way towards cancer personalized medicine. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.
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76 FR 62455 - Aerospace Safety Advisory Panel; Meeting
2011-10-07
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-088)] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel... Burch, Aerospace Safety Advisory Panel Administrative Officer, National Aeronautics and Space...
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78 FR 1265 - Aerospace Safety Advisory Panel; Meeting
2013-01-08
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 13-001] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel..., Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space Administration...
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[Burnout effect on academic progress of Oncology medical residents].
González-Ávila, Gabriel; Bello-Villalobos, Herlinda
2014-01-01
In the formative period of the courses taken in medical specializations, new and greater responsibilities are accepted by physicians in personal and academic spheres. The interaction of several factors that encompass the practice of these physicians could surpass their capacity to cope, causing on these professionals a high level of stress and professional exhaustion, which will affect their academic development. The objective of this research was to establish if the occupational stress of these medical residents affects their academic progress. We administered the Spanish version of the Maslach Burnout Inventory (MBI) to 52 residents of three specializations in Oncology (Medical Oncology, Surgical Oncology, and Radio-Oncology). These residents accepted voluntarily at the same time of their third cognitive exam. The prevalence of burnout syndrome was 13.5 %, with a high frequency among medical residents of first degree. Medical Oncology residents showed a higher emotional exhaustion and lower personal fulfillment. Considering the three specializations, the academic progress was higher in the third year, with a significant difference to Surgical Oncology and Medical Oncology (p = 0.026 and 0.015, respectively). No significant difference was found between burnout syndrome, academic progress and sociodemographic characteristics. The presence of burnout syndrome does not affect the academic progress of Oncology medical residents.
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76 FR 19147 - Aerospace Safety Advisory Panel; Meeting.
2011-04-06
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-030)] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel.... Kathy Dakon, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space...
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78 FR 56941 - Aerospace Safety Advisory Panel; Meeting
2013-09-16
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: 13-114] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel.... Harmony Myers, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space...
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77 FR 25502 - Aerospace Safety Advisory Panel; Meeting
2012-04-30
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (12-030)] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel... FURTHER INFORMATION CONTACT: Ms. Harmony Myers, Aerospace Safety Advisory Panel Executive Director...
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77 FR 38090 - Aerospace Safety Advisory Panel; Meeting.
2012-06-26
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 12-044] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel.... Harmony Myers, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space...
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75 FR 61219 - Aerospace Safety Advisory Panel; Meeting
2010-10-04
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-116)] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel... Dakon, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space Administration...
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77 FR 58413 - Aerospace Safety Advisory Panel; Meeting
2012-09-20
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 12-074] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel.... Harmony Myers, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space...
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Integration of oncology and palliative care: a systematic review.
Hui, David; Kim, Yu Jung; Park, Ji Chan; Zhang, Yi; Strasser, Florian; Cherny, Nathan; Kaasa, Stein; Davis, Mellar P; Bruera, Eduardo
2015-01-01
Both the American Society of Clinical Oncology and the European Society for Medical Oncology strongly endorse integrating oncology and palliative care (PC); however, a global consensus on what constitutes integration is currently lacking. To better understand what integration entails, we conducted a systematic review to identify articles addressing the clinical, educational, research, and administrative indicators of integration. We searched Ovid MEDLINE and Ovid EMBase between 1948 and 2013. Two researchers independently reviewed each citation for inclusion and extracted the indicators related to integration. The inter-rater agreement was high (κ = 0.96, p oncology journals (59%) and in or after 2010 (64%, p oncology and PC. ©AlphaMed Press.
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Hijjawi, Nawal; Zahedi, Alireza; Kazaleh, Mahmoud; Ryan, Una
2017-11-01
Cryptosporidiosis is a protozoan parasitic disease which affects human and animals worldwide. In adult immunocompetent individuals, cryptosporidiosis usually results in acute and self-limited diarrhoea; however, it can cause life threatening diarrhoea in children and immunocompromised individuals. In the present study, we compared the prevalence of Cryptosporidium species and gp60 subtypes amongst paediatric oncology patients with diarrhoea (n=160) from King Hussein Medical Centre for Cancer in Jordan, and non-oncology paediatric patients with diarrhoea (n=137) from Al-Mafraq paediatric hospital. Microscopy results using modified acid fast staining identified a significantly (p≤0.05) higher prevalence of Cryptosporidium in paediatric oncology patients with diarrhoea (14.4% - 23/160), compared to non-oncology paediatric patients with diarrhoea only (5.1% - 7/137). With the exception of one sample, all microscopy-positive samples (n=29) and an additional 3/30 microscopy-negative controls were typed to species and subtype level at the 18S and gp60 loci, respectively. All Cryptosporidium positives were typed as C. parvum. Of the 22 typed Cryptosporidium positives from the paediatric oncology patients, 21 were subtyped as IIaA17G2R1 and one as IIaA16G2R1 C. parvum subtypes. The 7 typed positives from the paediatric patients from Al-Mafraq hospital were subtyped as IIaA17G2R1 (n=5) and IIaA16G2R1 (n=2). The 3 additional positives from the 30 microscopy negative control samples were subtyped as IIaA17G2R1. The high prevalence of the IIaA17G2R1 subtype, particularly amongst oncology patients, suggests that an outbreak of cryptosporidiosis may have been occurring in oncology patients during the collection period (April to December, 2016). New therapies for cryptosporidiosis in immunocompromised patients are urgently required. Copyright © 2017 Elsevier B.V. All rights reserved.
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2011-10-18
... FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital Age AGENCY: Federal Communications Commission. ACTION: Notice of... Communications in the Digital Age (``Diversity Committee''). The Committee's mission is to provide...
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2012-09-17
... FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital Age AGENCY: Federal Communications Commission. ACTION: Notice of... Communications in the Digital Age (``Diversity Committee''). The Committee's mission is to provide...
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2012-02-07
... FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital Age AGENCY: Federal Communications Commission. ACTION: Notice of... Communications in the Digital Age (``Diversity Committee''). The Committee's mission is to provide...
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2013-04-10
... FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital Age AGENCY: Federal Communications Commission. ACTION: Notice of... Communications in the Digital Age (``Diversity Committee''). The Committee's mission is to provide...
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Pharmacy Instruction in Medical Oncology: Results of a National Survey.
Cersosimo, Robert J.
1989-01-01
A survey concerning oncology instruction in pharmacy schools found it taught primarily as part of a course in medicinal chemistry/pharmacology or therapeutics. Twenty-one schools offer an oncology course, with others planning them. Oncology clerkships are currently available in 42 schools. Increased emphasis on oncology instruction is encouraged.…
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75 FR 6407 - Aerospace Safety Advisory Panel; Meeting
2010-02-09
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10- 020)] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel... FURTHER INFORMATION CONTACT: Ms. Kathy Dakon, Aerospace Safety Advisory Panel Executive Director, National...
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Gibson, E J; Begum, N; Koblbauer, I; Dranitsaris, G; Liew, D; McEwan, P; Tahami Monfared, A A; Yuan, Y; Juarez-Garcia, A; Tyas, D; Lees, M
2018-01-01
Economic models in oncology are commonly based on the three-state partitioned survival model (PSM) distinguishing between progression-free and progressive states. However, the heterogeneity of responses observed in immuno-oncology (I-O) suggests that new approaches may be appropriate to reflect disease dynamics meaningfully. This study explored the impact of incorporating immune-specific health states into economic models of I-O therapy. Two variants of the PSM and a Markov model were populated with data from one clinical trial in metastatic melanoma patients. Short-term modeled outcomes were benchmarked to the clinical trial data and a lifetime model horizon provided estimates of life years and quality adjusted life years (QALYs). The PSM-based models produced short-term outcomes closely matching the trial outcomes. Adding health states generated increased QALYs while providing a more granular representation of outcomes for decision making. The Markov model gave the greatest level of detail on outcomes but gave short-term results which diverged from those of the trial (overstating year 1 progression-free survival by around 60%). Increased sophistication in the representation of disease dynamics in economic models is desirable when attempting to model treatment response in I-O. However, the assumptions underlying different model structures and the availability of data for health state mapping may be important limiting factors.
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2010-03-24
... DEPARTMENT OF COMMERCE International Trade Administration U.S. Travel And Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board AGENCY: International Trade Administration, U.S. Department of Commerce. ACTION: Notice of an open meeting. SUMMARY: The U.S. Travel and Tourism Advisory...
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2010-04-01
... DEPARTMENT OF COMMERCE International Trade Administration U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board AGENCY: International Trade Administration, U.S... Tourism Advisory Board (Board) will hold a meeting to discuss topics related to the travel and tourism...
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2010-07-09
... DEPARTMENT OF COMMERCE International Trade Administration U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board AGENCY: International Trade Administration, U.S. Department of Commerce. ACTION: Notice of an open meeting. SUMMARY: The U.S. Travel and Tourism Advisory...
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77 FR 56242 - Dodd-Frank Investor Advisory Committee
2012-09-12
... Investor Advisory Committee AGENCY: Securities and Exchange Commission. ACTION: Notice of Meeting of Securities and Exchange Commission Dodd- Frank Investor Advisory Committee. SUMMARY: The Securities and Exchange Commission Investor Advisory Committee, established pursuant to Section 911 of the Dodd-Frank Wall...
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78 FR 43254 - Dodd-Frank Investor Advisory Committee
2013-07-19
... Investor Advisory Committee AGENCY: Securities and Exchange Commission. ACTION: Notice of Meeting of Securities and Exchange Commission Dodd- Frank Investor Advisory Committee. SUMMARY: The Securities and Exchange Commission Investor Advisory Committee, established pursuant to Section 911 of the Dodd-Frank Wall...
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78 FR 20156 - Dodd-Frank Investor Advisory Committee
2013-04-03
... Investor Advisory Committee AGENCY: Securities and Exchange Commission. ACTION: Notice of Meeting of Securities and Exchange Commission Dodd- Frank Investor Advisory Committee. SUMMARY: The Securities and Exchange Commission Investor Advisory Committee, established pursuant to Section 911 of the Dodd-Frank Wall...
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78 FR 2706 - Dodd-Frank Investor Advisory Committee
2013-01-14
... Investor Advisory Committee AGENCY: Securities and Exchange Commission. ACTION: Notice of Meeting of Securities and Exchange Commission Dodd- Frank Investor Advisory Committee. SUMMARY: The Securities and Exchange Commission Investor Advisory Committee, established pursuant to Section 911 of the Dodd-Frank Wall...
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78 FR 36793 - Aerospace Safety Advisory Panel; Meeting
2013-06-19
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 13-068] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel..., Huntsville, AL 35805 FOR FURTHER INFORMATION CONTACT: Ms. Harmony Myers, Aerospace Safety Advisory Panel...
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Standish, Leanna J; Dowd, Fred; Sweet, Erin; Dale, Linda; Andersen, M Robyn
2018-04-01
To determine if women with breast cancer who choose adjunctive naturopathic oncology (NO) specialty care receive different standard oncologic treatment when compared with breast cancer patients who receive only standard care. Women with breast cancer stages 0 to 4, aged 18+ who spoke English and sought care from outpatient naturopathic doctor clinics were enrolled in an observational study of clinical and quality of life outcomes. Women who sought NO care 2 or more times within the first 2 years postdiagnosis were identified as NO cases. A matched comparison group of breast cancer patients were identified using the Western Washington Cancer Surveillance System(CSS). A longitudinal cohort design. In addition to self-report data, the CSS provided data on demographics, stage at the time of diagnosis, and initial treatment. Oncology medical records were abstracted in order to provide additional information on standard oncologic treatment for all participants. Cohorts were well matched with regard to demographic, histologic, and prognostic indicators at the time of diagnosis. Approximately 70% of women in both cohorts received standard oncologic care that met the National Comprehensive Cancer Network guidelines. There were no statistically significant differences between the cohorts in treatment received. Fewer women in the NO cohort with estrogen receptor-positive breast cancer appear to have received antiestrogen therapy. Women in both cohorts appear to receive guideline-concordant care. However, women who receive adjunctive NO care may be less likely to receive antiestrogen therapy.
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2011-07-11
... ENVIRONMENTAL PROTECTION AGENCY [FRL-9435-3] Notification of Public Teleconferences of the Science... Protection Agency (EPA), Science Advisory Board Staff Office. ACTION: Notice. SUMMARY: The EPA Science... information concerning the EPA Science Advisory Board can be found at the EPA SAB Web site at http// www.epa...
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Energy Technology Data Exchange (ETDEWEB)
Bürglová, Kristýna; Hlaváč, Jan [Institute of Molecular and Translational Medicine, Palacký University Olomouc, Faculty of Medicine and Dentistry (Czech Republic); Bartlett, John R., E-mail: JBartlett@usc.edu.au [University of the Sunshine Coast, Faculty of Science, Health, Education and Engineering (Australia)
2015-12-15
Silica nanoparticles with tailored properties have been developed for a variety of biomedical applications, with particular emphasis on their use as carriers for the encapsulation and controlled release of bioactive species. Among the various strategies described, silica nanoparticles with uniform mesoporosity (MSN) prepared in aqueous solution at elevated temperatures using cetyltrimethylammonium bromide as a template have a range of desirable properties. However, the processing windows available to control the dimensions and other key properties of such nanoparticles prepared using fluoride salts as catalysts have not been elucidated, with mixed products containing gel fragments and non-uniform products obtained under many conditions. Here, we present a parametric study of the synthesis of MSN under fluoride-catalysed conditions using tetraethylorthosilicate as silica precursor. The processing conditions required to produce uniform nanoparticles with controlled dimensions are elucidated, together with the conditions under which dried powders can be re-dispersed in aqueous solution after long-term storage to regenerate unaggregated nanospheres with dimensions (as measured by dynamic light scattering) comparable to those measured via scanning electron microscopy analysis of the dried material. The ability to dry and store such powders for extended periods of time is an important requirement for the use of such materials in drug delivery applications. Preliminary results demonstrating the use of such MSNs as hosts for oncology drugs [substituted 3-hydroxyquinolinones (3-HQ)] with low water solubility (≪1 µg/g H{sub 2}O) are presented, with loadings of several wt% demonstrated. The ability of the silica host to protect the 3-HQ from oxidative degradation during impregnation and release is discussed.
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2013-12-06
..., HHS). (Catalogue of Federal Domestic Assistance Program Nos. 93.279, Drug Abuse and Addiction Research... Alcohol Abuse and Alcoholism; National Institute On Drug Abuse; and National Cancer Institute; Notice of....), notice is hereby given of a meeting of the National Advisory Council on Alcohol Abuse and Alcoholism...
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2011-01-28
... FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital Age AGENCY: Federal Communications Commission. ACTION: Notice of... Committee on Diversity for Communications in the Digital Age (``Diversity Committee''). ADDRESSES: A copy of...
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Industry Funding Among Leadership in Medical Oncology and Radiation Oncology in 2015.
Yoo, Stella K; Ahmed, Awad A; Ileto, Jan; Zaorsky, Nicholas G; Deville, Curtiland; Holliday, Emma B; Wilson, Lynn D; Jagsi, Reshma; Thomas, Charles R
2017-10-01
To quantify and determine the relationship between oncology departmental/division heads and private industry vis-à-vis potential financial conflict of interests (FCOIs) as publicly reported by the Centers for Medicare and Medicaid Services Open Payments database. We extracted the names of the chairs/chiefs in medical oncology (MO) and chairs of radiation oncology (RO) for 81 different institutions with both RO and MO training programs as reported by the Association of American Medical Colleges. For each leader, the amount of consulting fees and research payments received in 2015 was determined. Logistic modeling was used to assess associations between the 2 endpoints of receiving a consulting fee and receiving a research payment with various institution-specific and practitioner-specific variables included as covariates: specialty, sex, National Cancer Institute designation, PhD status, and geographic region. The majority of leaders in MO were reported to have received consulting fees or research payments (69.5%) compared with a minority of RO chairs (27.2%). Among those receiving payments, the average (range) consulting fee was $13,413 ($200-$70,423) for MO leaders and $6463 ($837-$16,205) for RO chairs; the average research payment for MO leaders receiving payments was $240,446 ($156-$1,234,762) and $295,089 ($160-$1,219,564) for RO chairs. On multivariable regression when the endpoint was receipt of a research payment, those receiving a consulting fee (odds ratio [OR]: 5.34; 95% confidence interval [CI]: 2.22-13.65) and MO leaders (OR: 5.54; 95% CI: 2.62-12.18) were more likely to receive research payments. Examination of the receipt of consulting fees as the endpoint showed that those receiving a research payment (OR: 5.41; 95% CI: 2.23-13.99) and MO leaders (OR: 3.06; 95% CI: 1.21-8.13) were more likely to receive a consulting fee. Leaders in academic oncology receive consulting or research payments from industry. Relationships between oncology leaders and
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2010-12-21
... DEPARTMENT OF COMMERCE International Trade Administration U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board AGENCY: International Trade Administration, U.S... agenda for an open meeting of the U.S. Travel and Tourism Advisory Board (Board). The agenda may change...
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2011-04-18
... DEPARTMENT OF COMMERCE International Trade Administration U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board AGENCY: International Trade Administration, U.S... agenda for an open meeting of the U.S. Travel and Tourism Advisory Board (Board). The agenda may change...
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2011-08-29
... DEPARTMENT OF COMMERCE International Trade Administration U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board AGENCY: International Trade Administration, U.S... agenda for an open meeting of the U.S. Travel and Tourism Advisory Board (Board). The agenda may change...
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Information technologies for radiation oncology
International Nuclear Information System (INIS)
Chen, George T.Y.
1996-01-01
Electronic exchange of information is profoundly altering the ways in which we share clinical information on patients, our research mission, and the ways we teach. The three panelists each describe their experiences in information exchange. Dr. Michael Vannier is Professor of Radiology at the Mallinkrodt Institute of Radiology, and directs the image processing laboratory. He will provide insights into how radiologists have used the Internet in their specialty. Dr. Joel Goldwein, Associate Professor in the Department of Radiation Oncology at the University of Pennsylvania, will describe his experiences in using the World Wide Web in the practice of academic radiation oncology and the award winning Oncolink Web Site. Dr. Timothy Fox Assistant, Professor of Radiation Oncology at Emory University will discuss wide area networking of multi-site departments, to coordinate center wide clinical, research and teaching activities
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Radiation Therapy Oncology Group clinical trials with misonidazole
International Nuclear Information System (INIS)
Wasserman, T.H.; Stetz, J.; Phillips, T.L.
1981-01-01
This paper presents a review of the progressive clinical trials of the hypoxic cell radiosensitizer, misonidazole, in the Radiation Therapy Oncology Group (RTOG). Presentation is made of all the schemas of the recently completed and currently active RTOG Phase II and Phase III studies. Detailed information is provided on the clinical toxicity of the Phase II trials, specifically regarding neurotoxicity. With limitations in drug total dose, a variety of dose schedules have proven to be tolerable, with a moderate incidence of nausea and vomiting and mild peripheral neuropathy or central neuropathy. No other organ toxicity has been seen, specifically no liver, renal or bone marrow toxicities. An additional Phase III malignant glioma trial in the Brain Tumor Study Group is described
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Evidence on the cost of breast cancer drugs is required for rational decision making
Berghuis, Anne Margreet Sofie; Koffijberg, Hendrik; Terstappen, Leonardus Wendelinus Mathias Marie; Sleijfer, Stefan; IJzerman, Maarten Joost
2018-01-01
Background: For rational decision making, assessing the cost-effectiveness and budget impact of new drugs and comparing the costs of drugs already on the market is required. In addition to value frameworks, such as the American Society of Clinical Oncology Value Framework and the European Society of
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77 FR 29705 - Dodd-Frank Investor Advisory Committee
2012-05-18
... Investor Advisory Committee AGENCY: Securities and Exchange Commission. ACTION: Notice of First Meeting of Securities and Exchange Commission Dodd-Frank Investor Advisory Committee. SUMMARY: The Securities and Exchange Commission Investor Advisory Committee, established pursuant to Section 911 of the Dodd-Frank Wall...
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78 FR 15937 - Fusion Energy Sciences Advisory Committee
2013-03-13
... DEPARTMENT OF ENERGY Fusion Energy Sciences Advisory Committee AGENCY: Department of Energy, Office of Science. ACTION: Notice of open meeting. SUMMARY: This notice announces a meeting of the Fusion Energy Sciences Advisory Committee. The Federal Advisory Committee Act requires that public notice of...
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77 FR 5246 - Basic Energy Sciences Advisory Committee
2012-02-02
... DEPARTMENT OF ENERGY Basic Energy Sciences Advisory Committee AGENCY: Office of Science... of the Basic Energy Sciences Advisory Committee (BESAC). The Federal Advisory Committee Act (Pub. L... FURTHER INFORMATION CONTACT: Katie Perine; Office of Basic Energy Sciences; U.S. Department of Energy...
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78 FR 2259 - Fusion Energy Sciences Advisory Committee
2013-01-10
... DEPARTMENT OF ENERGY Fusion Energy Sciences Advisory Committee AGENCY: Office of Science... Energy Sciences Advisory Committee. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770... Energy Sciences; U.S. Department of Energy; 1000 Independence Avenue SW.; Washington, DC 20585-1290...
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77 FR 70807 - Advisory Board for Exceptional Children
2012-11-27
... DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs Advisory Board for Exceptional Children AGENCY... (BIE) is announcing that the Advisory Board for Exceptional Children (Advisory Board) will hold its... with Disabilities Education Act of 2004 (IDEA) for Indian children with disabilities. DATES: The...
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76 FR 40929 - Advisory Board for Exceptional Children
2011-07-12
... DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs Advisory Board for Exceptional Children AGENCY... (BIE) is announcing that the Advisory Board for Exceptional Children (Advisory Board) will hold its... with Disabilities Education Act of 2004 (IDEA) for Indian children with disabilities. DATES: The...
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77 FR 47873 - Advisory Board for Exceptional Children
2012-08-10
... DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs Advisory Board for Exceptional Children AGENCY... (BIE) is announcing that the Advisory Board for Exceptional Children (Advisory Board) will hold its... with Disabilities Education Act of 2004 (IDEA) for Indian children with disabilities. DATES: The...
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75 FR 50780 - Advisory Board for Exceptional Children
2010-08-17
... DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs Advisory Board for Exceptional Children AGENCY... (BIE) is announcing that the Advisory Board for Exceptional Children (Advisory Board) will hold its... with Disabilities Education Act of 2004 (IDEA) for Indian children with disabilities. DATES: The...