去中心化臨床試驗（DCT）是指在傳統(tǒng)臨床試驗場所以外的場所進行部分或全部與試驗相關(guān)活動的臨床試驗。DCT可以提高試驗效率，減輕受試者負擔，提高其參與度，吸納更多的多樣化受試人群，加速藥物開發(fā)。美國食品藥品管理局（FDA）于2023年5月發(fā)布了“藥物、生物制品和器械去中心化臨床試驗供企業(yè)、研究者和其他利益相關(guān)者用的指導(dǎo)原則草案”。該指導(dǎo)原則草案對DCT下列諸多方面提出了很多具體建議：DCT設(shè)計、遠程臨床試驗訪問和臨床試驗相關(guān)活動、數(shù)字健康技術(shù)、申請人和研究者的作用和責任、知情同意和倫理審查委員會監(jiān)督、DCT中的研究性藥物、研究性藥物的包裝和運輸、安全監(jiān)測計劃和DCT使用的軟件。這些建議有重要參考價值，而中國目前還沒有專門針對DCT的指導(dǎo)原則。詳細介紹FDA該指導(dǎo)原則草案，期待對中國開展DCT及其監(jiān)管有所益處。

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 The FDA issued the Decentralized Clinical Trials for Drugs, Biological Products, and Devices Draft Guidance for Industry, Investigators, and Other Stakeholders in May 2023. The draft guidance provides many specific recommendations for the following aspects of DCT: DCT design, remote clinical trial visits and clinical trial-related activities,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 This article provides a detailed introduction to the FDA draft guidance, hoping to be beneficial for China's DCTs and their supervision.