FDA“药物、生物制品和器械去中心化临床试验供企业、研究者和其他利益相关者用的指导原则”介绍

Introduction to FDA's Decentralized Clinical Trials for Drugs,Biological Products,,and Devices Guidance for Industry,Investigators,and Other Stakeholders

去中心化临床试验(DCT)是指在传统临床试验场所以外的场所进行部分或全部与试验相关活动的临床试验。DCT可以提高试验效率,减轻受试者负担,提高其参与度,吸纳更多的多样化受试人群,加速药物开发。美国食品药品管理局(FDA)于2023年5月发布了“药物、生物制品和器械去中心化临床试验供企业、研究者和其他利益相关者用的指导原则草案”。该指导原则草案对DCT下列诸多方面提出了很多具体建议:DCT设计、远程临床试验访问和临床试验相关活动、数字健康技术、申请人和研究者的作用和责任、知情同意和伦理审查委员会监督、DCT中的研究性药物、研究性药物的包装和运输、安全监测计划和DCT使用的软件。这些建议有重要参考价值,而中国目前还没有专门针对DCT的指导原则。详细介绍FDA该指导原则草案,期待对中国开展DCT及其监管有所益处。

The decentralized clinical trial(DCT)refers to a clinical trial where some or all of the trial-related activities occur at locations other than traditional clinical trial sites.DCTs can improve trial efficiencies,reduce the burden on subjects,improve their engagement,attract more diverse subjects,and accelerate drug development.The FDA issued the Decentralized Clinical Trials for Drugs,Biological Products,and Devices Draft Guidance for Industry,Investigators,and Other Stakeholders in May 2023.The draft guidance provides many specific recommendations for the following aspects of DCT:DCT design,remote clinical trial visits and clinical trial-related activities,digital health technologies,roles and responsibilities of sponsors and investigators,informed consent and institutional review board oversight,investigational products(IPs)in a DCT,packaging and transportation of IP,safety monitoring plan,and software used in conducting DCTs.These recommendations have important reference value.There is currently no specific guidance for DCTs in China.This article provides a detailed introduction to the FDA draft guidance,hoping to be beneficial for China's DCTs and their supervision.