药物临床试验方法学进展与质量管理规范教学新模式初步研究

Progress of Drug Clinical Trial Methodology and Pilot Study on New Model of Good Clinical Practice Teaching

目的探讨完善药物临床试验质量管理规范(good clinical practice,GCP)指南及改进传统GCP教学方法。方法采用定性研究的方法,形成GCP关键绩效指标(key performance indicators,KPI)。针对KPI采用线上和线下教学相结合的模式。并在药物临床试验监察过程中,对KPI的遵循进行持续质量改进。研究实用临床试验(pragmatic clinical trials,PCT)规律,形成新方法的GCP要求,并和国际指南相比较。结果应用定性研究的方法得到的GCP指南的KPI,具有代表性和可操作性,有利于GCP指南的掌握和遵循。针对KPI指标的持续质量改进项目,有利于药物临床试验质量提高。结论通过关键绩效指标的设立和持续质量改进等GCP教学新模式,可提高药物临床试验的质量。

Objective To investigate how to improve good clinical practice （GCP） Guideline in clinical trials and traditional teaching methods. Methods Key Performance Indicators （KPI） for GCP was established by the qualitative method. Online teaching and offline teaching of KPI were used. Continuous quality improvement was carried by complying with the KPI during the monitoring and inspection of clinical trials. GCP rules for pragmatic clinical trial （PCT） were set up and compared with the international regulations. Results KPI for GCP based on the qualitative research was representative and operable, which can help to understand and comply with the GCP guideline. Continuous quality improvement through KPI could be helpful for quality improvement of drug clinical trial. Conclusion The quality of drug clinical trial can be improved by the new teaching method of GCP of establishing the KPIs and continuous quality improvement.