Introduction to FDA's Decentralized Clinical Trials for Drugs,Biological Products,and Devices Guidance for Industry,Investigators,and Other Stakeholders
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accelerate drug development.The FDA issued the Decentralized Clinical Trials for Drugs,Biological Products,and Devices Draft Guidance for Industry,Investigators,and Other Stakeholders in May 2023.The draft guidance provides many specific recommendations for the following aspects of DCT:DCT design,remote clinical trial visits and clinical trial-related activities,digital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is currently no specific guidance for DCTs in China.This article provides a detailed introduction to the FDA draft guidance,hoping to be beneficial for China's DCTs and their supervision.
Food and Drug Administration(FDA)drugbiological productdevicedecentralized clinical trial(DCT)guidance
NETL
NSTL
万方数据
