Resources to assist in the transition to a single IRB model for multisite clinical trials
Resources to assist in the transition to a single IRB model for multisite clinical trials
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DOI：
10.1016/j.conctc.2019.100423
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发表时间：
2019-09-01
影响因子：
1.5
通讯作者：
Calvert, Sara
中科院分区：
文献类型：
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作者：
Hahn, Cynthia;Kaufmann, Petra;Calvert, Sara
2. IRB监督临床试验的监管要求是为了保护研究参与者而建立的，过去40年来为支持这一目标而发展的商业模式涉及美国各地数千个地方IRB和办事处的发展。随着临床研究企业的发展和多中心试验变得越来越普遍，目前还不清楚是否通过让每个中心的当地IRB对研究进行全面审查来加强保护研究参与者的目标。对多个当地IRB进行全面审查的一个直观反对意见是涉及额外的时间和费用[[3]，[4]，[5]]。2006年，美国食品药品监督管理局（FDA）召开了一次关于替代IRB模式的全国会议[6]，并发布了多中心临床试验集中IRB使用指南，鼓励使用，特别是在可以提高IRB审查效率的情况下[7]。Jerry Menikoff博士2010年在《新英格兰医学杂志》上发表的社论[8]指出，这可能是一个伦理问题，也是一个效率问题，因为多个当地IRB审查同一项多中心研究会导致责任分散，并可能使试验参与者面临不适当的风险。尽管有这种联邦支持，但当地IRB在多中心试验中是否愿意接受sIRB审查方面仍然存在差异[9]。
2. BackgroundThe regulatory requirement for IRB oversight of clinical trials was established to protect research participants, and the business model that developed over the past 40 years to support this goal involved the development of thousands of local IRBs and offices across the United States. As the clinical research enterprise evolved and multisite trials became more common, it was unclear whether the goal of protecting research participants was enhanced by having each site's local IRB conduct a full review of the research study. One intuitive objection to full review by multiple local IRBs is the additional time and expense involved [[3],[4],[5]]. In 2006, a National Conference on Alternative IRB Models was held [6] and the US Food and Drug Administration (FDA) issued a guidance for centralized IRB use for multicenter clinical trials, encouraging use especially in situations where it could improve the efficiency of IRB review [7]. Dr. Jerry Menikoff's editorial in the New England Journal of Medicine in 2010 [8] suggested that this might be an ethical issue as well as an efficiency issue because multiple local IRBs reviewing the same multisite study leads to a diffusion of responsibility and potentially exposes trial participants to undue risks. Despite this federal support, local IRBs continued to vary in their willingness to defer to sIRB review for multisite trials [9].