简化实用随机临床试验的机构审查委员会流程：来自阿司匹林剂量：评估获益和长期效果的以患者为中心的试验（ADAPTABLE）试验的挑战和经验教训。
Streamlining the institutional review board process in pragmatic randomized clinical trials: challenges and lessons learned from the Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) trial.
机构信息
Duke Clinical Research Institute, 200 Morris St, Durham, NC, 27701, USA.
Duke University Medical Center, 2301 Erwin Road, Durham, NC, 27710, USA.
出版信息
Trials. 2021 Jan 25;22(1):90. doi: 10.1186/s13063-021-05026-w.
BACKGROUND
New considerations during the ethical review processes may emerge from innovative, yet unfamiliar operational methods enabled in pragmatic randomized controlled trials (RCT), potentially making institutional review board (IRB) evaluation more complex. In this manuscript, key components of the pragmatic "Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE)" randomized trial that required a reappraisal of the IRB submission, review, and approval processes are discussed.
MAIN TEXT
ADAPTABLE is a pragmatic, multicenter, open-label RCT evaluating the comparative effectiveness of two doses of aspirin widely used for secondary prevention (81 mg and 325 mg) in 15,000 patients with an established history of atherosclerotic cardiovascular disease. The electronic informed consent form is completed online by the participants at the time of enrollment, and endpoint ascertainment is conducted through queries of electronic health records. IRB challenges encountered regarding centralized IRB evaluation, electronic informed consent, patient engagement, and risk determination in ADAPTABLE are described in this manuscript. The experience of ADAPTABLE encapsulates how pragmatic protocol components intended to facilitate the study conduct have been tempered by unexpected, yet justified concerns raised by local IRBs. How the lessons learned can be applied to future similar pragmatic trials is delineated.
CONCLUSION
Development of engaging communication channels between IRB and study personnel in pragmatic randomized trials as early as at the time of protocol design allows to reduce issues with IRB approval. Integrations of the lessons learned in ADAPTABLE regarding the IRB process for centralized IRBs, informed consent, patient engagement, and risk determination can be emulated and will be instrumental in future pragmatic studies.
背景
创新性但不熟悉的实用随机对照试验（RCT）操作方法可能会引发伦理审查过程中的新问题，从而使机构审查委员会（IRB）的评估更加复杂。本文讨论了实用的“阿司匹林剂量：评估获益和长期效果的患者为中心试验（ADAPTABLE）”随机试验的关键组成部分，这些部分需要重新评估 IRB 的提交、审查和批准过程。
主要文本
ADAPTABLE 是一项实用的、多中心、开放性 RCT，评估了两种广泛用于二级预防的阿司匹林剂量（81mg 和 325mg）在 15000 名有明确动脉粥样硬化性心血管疾病史的患者中的比较效果。参与者在注册时在线完成电子知情同意书，通过查询电子健康记录来确定终点。本文描述了 ADAPTABLE 中遇到的与集中式 IRB 评估、电子知情同意、患者参与和风险确定有关的 IRB 挑战。ADAPTABLE 的经验说明了旨在促进研究进行的实用方案组成部分如何受到当地 IRB 提出的意外但合理的关注的影响。本文还阐述了如何将在 ADAPTABLE 中吸取的经验教训应用于未来类似的实用试验。
结论
在实用随机试验中尽早在协议设计阶段建立 IRB 和研究人员之间的沟通渠道，可以减少 IRB 批准方面的问题。可以效仿 ADAPTABLE 中关于集中式 IRB、知情同意、患者参与和风险确定的 IRB 流程的经验教训，并将其应用于未来的实用研究中。
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