A Road Map for Peer Review of Real-World Evidence Studies on Safety and Effectiveness of Treatments.
A Road Map for Peer Review of Real-World Evidence Studies on Safety and Effectiveness of Treatments.
复制标题
作者：
在临床和监管决策中越来越多地接受真实世界证据（RWE），加上医疗保健数据的可用性越来越高以及自动化分析方法的进步，导致糖尿病和其他疾病的RWE研究显着扩展。然而，最近一系列引人注目的撤稿事件凸显了RWE研究以及相关同行评审和编辑过程需要改进。我们回顾了RWE研究的最佳药物流行病学实践和有关设计、测量、分析、数据有效性、适当性和普遍性的常见陷阱。为了加强RWE研究评估，我们建议期刊编辑要求1）研究作者完成RECORD-PE，这是一项关于常规收集数据的药物流行病学研究报告指南，2）预定研究方案和分析计划的可用性，3）同行评审团队中包括药物流行病学家，以及4）提供数据来源，表征，和保管，以促进对数据源的评估。我们认识到，这些步骤都不能保证高质量的研究。然而，总体而言，它们允许对研究是否充分设计和实施以及所使用的数据源是否适合目的进行知情评估。
The growing acceptance of real-world evidence (RWE) in clinical and regulatory decision-making, coupled with increasing availability of health care data and advances in automated analytic approaches, has contributed to a marked expansion of RWE studies of diabetes and other diseases. However, a recent spate of high-profile retractions highlights the need for improvements in the conduct of RWE research as well as in the associated peer review and editorial processes. We review best pharmacoepidemiologic practices and common pitfalls regarding design, measurement, analysis, data validity, appropriateness, and generalizability of RWE studies. To enhance RWE study assessments, we propose that journal editors require 1) study authors to complete RECORD-PE, a reporting guideline for pharmacoepidemiological studies on routinely collected data, 2) availability of predetermined study protocols and analysis plans, 3) inclusion of pharmacoepidemiologists on the peer review team, and 4) provision of detail on data provenance, characterization, and custodianship to facilitate assessment of the data source. We recognize that none of these steps guarantees a high-quality research study. Collectively, however, they permit an informed assessment of whether the study was adequately designed and conducted and whether the data source used was fit for purpose.
影响因子：
16.2
作者：
通讯作者：
--
影响因子：
2.6
作者：
Winterstein, Almut G.;Kubilis, Paul;Bird, Steve;Cooper-DeHoff, Rhonda M.;Nichols, Greg A.;Delaney, Joseph A.
通讯作者：
Delaney, Joseph A.