临床试验参与者管理常见问题及应对策略探讨

Problems and Countermeasures of the Participants Management during Clinical Trials

摘要: 目的：梳理参与者参加临床试验常见的问题，探讨临床试验中保护参与者安全、实现参与者利益最大化且风险最小化的策略及注意事项。方法：结合临床试验相关法律、规范性文件要求以及笔者实践经验，分析临床试验流程和操作、相关方职责及行为等造成的临床试验参与者相关风险和常见问题。结果：临床试验设计、供应商选择、人员培训、参与者筛选和随访、监督管理等临床试验相关操作均可能影响参与者权益和安全保障。结论：申办者、临床试验机构、伦理委员会、招募方及现场管理组织等相关方共同协作，充分调动参与者及其陪护人员的主动性，严格执行试验方案，可有效减少临床试验中参与者相关问题。

Abstract: Objective: To summarize common issues, explore strategies and precautions for protecting participants’ safety, maximizing benefits, and minimizing risks of participants in clinical trials. Methods: Based on the requirements of clinical research related management laws and regulations, normative documents, and the author’s practical experience, analyze the risks and common issues related to clinical trial participants caused by the clinical trial process and operations, stakeholder responsibilities and behaviors. Results: Clinical trial design, supplier selection, personnel training, participants screening and follow-up, supervision and management, and other clinical trial related operations may affect the rights and safety of participants. Conclusions: Collaborating with relevant parties such as sponsors, clinical trial institutions, ethics committees, recruiters, and site management organizations, fully mobilizing the initiative of participants and their accompanying personnel, strictly implementing protocols, can effectively reduce issues related to participants in clinical trials.