近5年药物临床试验实施过程中存在问题的问卷调查

Investigation of Problems in Clinical Drug Trials in the Past 5 years

目的:了解近5年我国临床试验实施阶段存在的主要问题及可能的应对策略。方法:采取方便抽样的方法,以药物临床试验机构为研究现场,以参加过药物临床试验的医生为研究对象,采用自填式问卷调查相关问题,数据采用SPSS软件进行分析。结果:此次共调查147名医生,发现《药物临床试验质量管理规范》(GCP)培训率达90.48%,GCP的熟悉程度为70.8%。现阶段临床试验实施中存在的主要问题是不良事件记录、处理及随访的问题。调查发现"未对不良事件随访"发生率为10%,"遇到严重不良事件不知是否该揭盲处理"发生率为62.59%。结论:培养专职的临床研究护士,减轻临床试验研究者的工作内容,加强GCP培训的深度,针对不同人群进行更专业的培训,同时增加临床试验监查稽查的频率能够有效地提供临床试验的质量。

To understand the problems and solve them in the course of clinical drug trials in the past 5 years in China. Methods：Doctors joining in the clinical trials volunteered to fill in questionnaire. Results ：147 doctors par- ticipated in the survey. The rates of training in GCP and GCP familiarity were 90.48% and 70.8%, respectively. The main problems in the implementation were adverse events records, treatment and follow-up. Conclusion：The important measures of improving the quality of clinical trials included training clinical research coordinators and enhancing the depth of GCP training, and frequency of monitoring and auditing.