新药临床试验期间药物警戒和风险控制研究五:我国药物警戒和风险控制监管体系调研与结果分析

目的：对我国新药临床试验期间药物警戒和风险控制的关键问题与管理要素进行业内调研，探索加强该领域监管的可行措施。方法：在对欧美新药临床试验期间药物警戒体系，临床试验方案、研究者手册和知情同意书的监管要求，临床试验期间安全性定期报告监管要求以及药物临床试验期间个例安全性报告监管要求等文献研究的基础上，提炼关键管理要素，设计调研问卷，开展问卷调查，并对调查结果进行分析。采用非概率抽样法，选择从事与药物警戒相关工作的专业人员作为调研对象。结果与结论：调查结果反映出多数调研对象对我国新药临床试验期间药物警戒和风险控制的关键问题与管理要素有一定共识，本调研为进一步提出我国新药临床试验期间药物警戒和风险控制管理的完善建议提供了数据支持。

Research V on Pharmacovigilance and Risk Control During Clinical Trials of New Drugs: A Questionnaire Survey and Result Analysis on Regulatory System of Pharmacovigilance and Risk Control in China

Objective: To investigate the key issues and management elements of pharmacovigilance and risk control during clinical trials of new drugs in China and to come up with some feasible measures to strengthen supervision in this fi eld. Methods: Key management elements were refi ned based on previous literature researcheson the pharmacovigilance system during clinical trials of new drugs in Europe and the United States, on regulatory requirements for clinical trial protocols, investigator''s brochure and informed consent forms, on regulatory requirements for periodic safety reports during clinical trials, and on regulatory requirements for individual case safety reports during drug clinical trials. The questionnaire survey was designed and conducted, and the survey results were fi nally analyzed. The non-probability sampling method was used and the professionals engaged in the work of pharmacovigilance were selected as the research objects. Results and Conclusion: The survey results showed that most of the respondents had reached certain consensus on the key issues and management elements of pharmacovigilance and risk control during clinical trials of new drugs in China. This survey will off er a data support for further improvement in pharmacovigilance and risk control management during clinical trials of new drugs in China.