药物临床试验暂停与终止问题探析

An analysis of the suspension and termination issues of clinical trials

临床试验是一项严密计划、严格执行的科学实验活动。研究者往往期望按照研究计划完成试验。但由于疾病机制的不确定性、受试对象的多样性、干预措施的复杂性等因素,试验通常无法完全按照既定方案执行。全面回顾已注册临床试验实施详情发现,此类情况并不少见,常见的包括:临床试验目的提前完成或者明显无法完成,需要终止试验;试验出现了意外事件,如受试者不良反应、政策变更等,需要暂停试验以调整试验方案。但前期学界对此问题缺少针对性研究,有关临床试验暂停与终止的科学认识、原因分析、预案设计等均无明确解答。本文全面梳理了临床试验暂停与终止的相关因素,并尝试提出解决路径。

Clinical trials is a scientific experimental activity that needs thorough plan and strict execution.Investigators often expect to complete the trial according to the study plan.However,due to the uncertainty of disease mechanisms,the diversity of patients,and the complexity of interventions,trials usually cannot be executed exactly according to the established protocols.A comprehensive review of the implementation of registered clinical trials reveals that such situations are not uncommon and commonly include:the aim of the clinical trials is apparent inability to complete thus requiring termination of the trials;unexpected events,such as adverse reactions,policy changes,etc.,leading to suspend the trial and adjust the trial protocol.However,research on this issue is limited,and there is no definite answer on the scientific understanding,reason analysis,and plan design.In this paper,we comprehensively review the factors related to the suspension and termination of clinical trials and try to propose a solution.