真实世界研究的知情同意方式探讨

Norms of Informed Consent in Real-world Research/Study

如何利用真实世界证据(Real-world evidence,RWE)评价药物的有效性和安全性,已成为国内外药物研发和监管决策等方面共同关注的热点话题。真实世界研究(Real-world research/study,RWR/RWS)不同于临床实践,作为临床研究的一种类型,仍须基于医学伦理并科学开展,保护受试者权益仍是重中之重。知情同意是保障受试者权益的重要路径,做好知情同意非常关键。传统的知情同意方式在开展RWR/RWS过程中可能会导致招募困难或选择偏倚而降低研究结果的普适性,因此作者结合RWR/RWS的实际特点,探讨了在RWR/RWS范式下的知情同意方式的相关问题。

In recent years,how to use real-world evidence to evaluate the effectiveness and safety of drugs has become one of the hottest topics of common concern among the relevant regulatory agencies,pharmaceutical industry and academia.Domestic and foreign drug regulatory agencies have carried out a lot of discussions on how to use realworld evidence to support regulatory decision-making,which is reflected in the relevant guiding principles or framework documents.Real-world research/study is different from clinical practice.As a type of clinical research,it still needs to be carried out based on ethics and science,and protecting the rights and interests of subjects is still the top priority.Informed consent is absolutely the most important way,so appropriate informed consent becomes key tool.Traditional consent procedures have been said to diminish recruitment numbers and lead to unrepresentative samples,introducing selection bias.This paper mainly discusses the related issues of informed consent under the real world research paradigm.