去中心化临床试验设计和实施要点探析

Analysis on the key points in the design and implementation of decentralized clinical trials

去中心化临床试验(decentralized clinical trial,DCT)作为以患者为中心临床试验可供选择的模式之一,可以加快临床试验进程、改善受试者体验、提高临床试验数据质量。尽管如此,与大多数创新一样,DCT也增加了临床试验过程的复杂性,给临床试验带来额外风险。本文从DCT的特点与优势、应用的场景、设计实施需要考虑的因素、DCT元素引入、风险及应对措施进行探讨,以期为DCT的实践提供思路。

Decentralized Clinical Trials(DCT),as one of the clinical trial modes that can be selected in patient⁃centered clinical trials,can significantly shorten the time course of entering market for new drugs or devices,improve the experience of clinical trial participants and enhance the quality of clinical data.However,DCT,like most new innovations,will increase the complexity of the clinical trial process and may also bring in unknown risks.This article explores the features and advantages,the feasibility of application,the factors to consider in design and implementation,elements,risk and countermeasure of DCT,in order to provide references and ideas for the practice of DCT.