《药物临床试验期间方案变更技术指导原则(试行)》解读

Key points of technical guideline for protocol amendments during a drug clinical trial(interim)

2020年国家药品监督管理局修订发布了《药品注册管理办法》,其中第29条明确要求,药物临床试验期间,发生临床试验方案变更的,申办者应充分评估对受试者安全的影响,可能增加受试者安全风险的,应当提出补充申请。为了指导申办者科学、规范地开展临床期间方案变更相关工作,国家药品监督管理局药品审评中心制定发布了《药物临床试验期间方案变更技术指导原则(试行)》。本文对于《药物临床试验期间方案变更技术指导原则(试行)》起草背景进行介绍,并对方案变更评估要点、安全风险评估、变更分类、变更管理程序等进行分析和解读,以帮助对于指导原则的进一步理解和把握,供临床试验申办者、临床试验研究者及相关人员参考。

The Provisions for Drug Registration had been revised and issued by the National Medical Products Administration(NMPA) in 2020, in which Article 29 clearly requires that, in case of drug clinical trial protocol amendments during the drug clinical trial period, the sponsor should make a comprehensive assessment on the impact on the safety of subjects.If subject safety risks may be increased, a supplementary application should be filed. In order to guide the sponsor to carry out the protocol amendments during the drug clinical trial period scientifically and normatively, Center for Drug Evaluation, NMPA formulated and issued the Technical Guideline for Protocol Amendments during a Drug Clinical Trial(Interim).This article introduces the drafting background of the Technical Guideline for Protocol Amendments during a Drug Clinical Trial(Interim), analyzes and interprets the evaluation points, safety risk assessment, classification, management procedure of protocol amendments, so as to help the further understanding and grasp of the guideline, and provide references for sponsors, investigators and relevant personnel.