早期药物临床试验中健康受试者管理的 常见问题与对策

Common problems and strategies of healthy subjects management in early drug clinical trials

早期药物临床试验常以健康受试者为试验对象,与患者参与试验动机不同,健康受试者多以快速获得报酬为目的,且年龄、背景均与患者群体存在较大差异,因此试验期间对健康受试者的管理工作与患者也存在明显不同。本研究以健康受试者参加早期药物临床试验的全流程为主线,罗列从筛选、住院、出院等各个环节发现的真实问题,结合同行在该领域期刊公开发表的论文及笔者实际工作经验,分析探讨具体的原因及应对方法,为早期药物临床试验中健康受试者的管理工作提供参考,以更好地遵守药物临床试验质量管理规范,保障受试者的权益和安全、保证数据和结果的科学、真实,促进试验顺利进行。

Early drug clinical trials often focus on healthy subjects,with different motivations from patients to participate in the trial,healthy subjects often aim to quickly obtain compensation,and their age and background are significantly different from the patient population.Therefore,there are significant differences in the management of healthy subjects and patients during the trial period.This research takes the entire process of healthy subjects participating in early drug clinical trials as the main thread,listing the real problems found in various stages such as screening,hospitalization,and discharge.Combining with the published papers in journals in this field and author's actual work experience,this article analyzes and explores the specific causes and response methods,providing reference for the full process management of healthy subjects in early drug clinical trials,to better comply with the quality management standards of drug clinical trials,safeguard the rights and safety of subjects,ensure the scientific and truthful nature of data and results,and promote the smooth progress of trials.