Assessment of the risk/benefit ratio of phase II cancer clinical trials by Institutional Review Board (IRB) members
| Autor: | Albert W. Musschenga, H. E. M. van Luijn, Neil K. Aaronson, Ronald B. Keus, W. M. Robinson |
|---|---|
| Přispěvatelé: | Research in Practical Philosophy, Philosophy |
| Rok vydání: | 2002 |
| Předmět: |
Adult
Male medicine.medical_specialty Cancer clinical trial media_common.quotation_subject Decision Making Alternative medicine Medical Oncology Phase (combat) Risk Assessment Quality of life (healthcare) Clinical Trials Phase II as Topic SDG 3 - Good Health and Well-being Risk–benefit ratio Risk Factors Surveys and Questionnaires medicine Humans Ethics Medical media_common Aged business.industry Hematology Middle Aged Institutional review board humanities Oncology Feeling Family medicine Female business Psychosocial Ethics Committees Research |
| Zdroj: | van Luijn, H E M, Keus, R B, Robinson, W M & Aaronson, N K 2001, ' The Assessment of the risk/benefit ratio of phase II cancer clincal trials by Institutional Review Board (IRB) members ', Annals of Oncology, pp. 1307-1313 . https://doi.org/10.1093/annonc/mdf209 Musschenga, A W, Keus, R B, Robinson, W M & Aaronson, N K 2003, ' Assessment of the Risk/Benefit Ratio of Phase II Cancer Clinical Trials by Institutional Review Board (IRB) members ', Annals of Oncology, vol. 13, pp. 1307-1313 . https://doi.org/10.1093/annonc/mdf209 Annals of Oncology, 1307-1313. Oxford University Press STARTPAGE=1307;ENDPAGE=1313;ISSN=0923-7534;TITLE=Annals of Oncology Annals of Oncology, 13, 1307-1313. Oxford University Press |
| ISSN: | 0923-7534 |
| Popis: | Background: This study examined the assessment of risk/benefit ratios for phase II cancer clinical trials by Institutional Review Board (IRB) members. Patients and methods: Semi-structured interviews were conducted with 53 IRB members from six research hospitals and specialized cancer centers in The Netherlands. Results: While the toxicity and side-effects of treatment were most often identified as risks associated with participating in a phase II trial, approximately two-thirds of IRB members also cited psychosocial and/or quality-of-life risks. Conversely, 68% of the respondents identified psychosocial benefits of trial participation, while 25% cited treatment effectiveness as a possible benefit. Between one-quarter and two-thirds of respondents indicated that trial protocols provide insufficient information regarding the likelihood, magnitude and duration of both risks and benefits. Between 15% and 34% of IRB members reported feeling less than fully competent at evaluating various aspects of phase II protocols (e.g. originality and feasibility of the study, adequacy of the methods and analysis procedures, etc.). This was particularly the case for non-physician IRB members. Few IRB members reported weighing risks and benefits in a systematic manner, but rather relied on global impressions or preferred to leave such matters to the IRB as a whole or to their patients. Conclusions: A substantial minority of IRB members believes that trial protocols provide too little information relevant to evaluating various cost/benefit and scientific issues, and feels less than fully competent in carrying out such evaluations. IRB members are more likely to identify psychosocial benefits than physical health benefits that may accrue to patients participating in phase II trials. |
| Databáze: | OpenAIRE |
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