去中心化临床试验机构方(伦理、机构、研究者)审查要点专家共识2026年版

Expert consensus on review key points for institutional parties (ethics committees, institutions, and investigators) in decentralized clinical trials (2026 edition)

摘要

本专家共识旨在规范去中心化临床试验(decentralized clinical trials,DCT)中机构方(伦理审查委员会、机构管理部门、研究者)的审查职责与要点。随着DCT模式利用数字技术将试验延伸至患者生活场景,传统监管面临新挑战。共识基于ICH E6(R3)及中国《药物临床试验质量管理规范》等法规,系统梳理了DCT全生命周期的审查要点。伦理委员会需重点关注试验设计的伦理合理性、电子知情同意的实质等效性、隐私数据安全及弱势群体的特殊保护;机构管理部门应强化对项目合规性、第三方供应商管理、数据全流程质控及风险管理的审查;研究者则需确保远程评估的科学可靠性、试验参与者安全监护的及时性以及团队对新技术的执行力。共识强调三方应建立紧密协作机制,在保障试验参与者权益与安全的前提下,推动DCT在中国健康、有序发展,为行业提供可操作的实施指南。

Abstract

This expert consensus aims to standardize the review responsibilities and key points for institutional parties, including the Ethics Committees, Institutional Management Departments, and Investigators, in decentralized Clinical Trials (DCTs). As DCT approaches extend trials to participants' daily lives using digital technologies, traditional supervision faces new challenges. Based on the International Council for Harmonisation E6(R3) (ICH E6[R3]) and Chinese Good Clinical Practice (GCP) regulations, the consensus systematically outlines core review elements across the DCT lifecycle. Ethics Committees are required to focus on ethical rationale of the trial design, the substantive equivalence of electronic informed consent (eConsent), data privacy and security, and special protection of vulnerable populations. Institutional Management Departments should strengthen their review of regulatory compliance, third-party vendor management, end-to-end data quality control, and risk management. Investigators must ensure the scientific reliability of remote assessments, timely safety monitoring of trial participants, and their team's competency in implementing new technologies. The consensus emphasizes the need for a close collaboration mechanism among these three parties to promote the healthy and orderly development of DCT approaches in China while safeguarding participant rights and safety, thereby providing actionable guide for the industry.

关键词

去中心化临床试验 / 机构方 / 审查要点 / 专家共识

Key words

decentralized clinical trials / institutional parties / key review points / expert consensus

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基金资助

上海市卫生健康委员会智慧医疗专项(2025ZHYL037);上海市教育委员会“中医药临床评价新技术协同育人团队”项目