Van Luijn H E M, Musschenga A W, Keus R B, Robinson W M, Aaronson N K
Institute for Ethics, the Vrije Universiteit, Amsterdam, The Netherlands.
Ann Oncol. 2002 Aug;13(8):1307-13. doi: 10.1093/annonc/mdf209.
This study examined the assessment of risk/benefit ratios for phase II cancer clinical trials by Institutional Review Board (IRB) members.
Semi-structured interviews were conducted with 53 IRB members from six research hospitals and specialized cancer centers in The Netherlands.
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.
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.
本研究调查了机构审查委员会(IRB)成员对癌症II期临床试验风险/收益比的评估。
对来自荷兰六家研究医院和专业癌症中心的53名IRB成员进行了半结构化访谈。
虽然治疗的毒性和副作用最常被确定为参与II期试验相关的风险,但约三分之二的IRB成员也提到了心理社会和/或生活质量风险。相反,68%的受访者指出参与试验有心理社会效益,而25%的受访者认为治疗效果可能是一种益处。四分之一至三分之二的受访者表示,试验方案提供的关于风险和益处的可能性、程度和持续时间的信息不足。15%至34%的IRB成员报告称,在评估II期试验方案的各个方面(如研究的原创性和可行性、方法和分析程序的充分性等)时,感觉自己能力不足。非医生IRB成员尤其如此。很少有IRB成员报告称以系统的方式权衡风险和益处,而是依赖总体印象,或者更愿意将此类事项留给整个IRB或他们的患者。
相当少数的IRB成员认为试验方案提供的与评估各种成本/效益和科学问题相关的信息太少,并且在进行此类评估时感觉能力不足。IRB成员更有可能识别出参与II期试验的患者可能获得的心理社会效益,而非身体健康益处。