期刊
CLINICAL TRIALS
卷 19, 期 2, 页码 211-216出版社
SAGE PUBLICATIONS LTD
DOI: 10.1177/17407745211063476
关键词
Research risk; pragmatic; comparative effectiveness; standard of care
资金
- NIH [CL010538]
This study presents a practical four-step process for determining the research risk of pragmatic randomized clinical trials that compare standard interventions. It provides a transparent and systematic approach with low risk of bias.
Background: Pragmatic randomized clinical trials that compare two or more purportedly within the standard of care interventions attempt to provide real-world evidence for policy and practice decisions. There is considerable debate regarding their research risk status, which in turn could lead to debates about appropriate consent requirements. Yet no practical guidance for identifying the research risks of pragmatic randomized clinical trials is available. Methods: We developed a practical, four-step process for identifying and evaluating the research risk of pragmatic trials that can be applied to those pragmatic randomized clinical trials that compare two or more standard of care or accepted interventions. Results: Using a variety of examples of standard of care pragmatic randomized clinical trials (ranging from trials comparing: insurance coverage conditions, patient reminders for health screens, intensive care unit procedures, post-stroke interventions, and drugs for life-threatening conditions), we illustrate in a four-step process how any pragmatic randomized clinical trial purportedly comparing standard interventions can be evaluated for their research risks. Conclusion: Although determining the risk status of a standard of care pragmatic randomized clinical trial is only one necessary element in the ethical oversight of such pragmatic randomized clinical trials, it is a central element. Our four-step process of pragmatic randomized clinical trial risk determination provides a practical, transparent, and systematic approach with likely low risk of bias.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据