药物临床试验的风险与管理

Risk and Management in Clinical Drug Trial

目的:加强药物临床试验风险管理,实现风险最小化。方法:基于现代风险管理的理论,联系目前国内临床试验的实际情况,综合分析,提出意见和建议。结果:目前的模式下,临床试验风险的存在是客观和必然的,通过风险预测、规范操作、加强不良反应监测等措施可以减少和规避风险。结论:药物临床试验是有风险的,实行风险管理十分必要。

OBJECTIVE： To strengthen the risk management in clinical drug trial so as to minimize the risk. METHODS： Based on modern risk management theory as well as the practical condition of the current clinical drug trial, an aggregate analysis was done and some opinions and suggestions were put forward. RESULTS： Under current model, it is objective and inevitable for the risks involved in clinical trial, but which could be reduced or avoided by taking some effective measures such as risk predication, standardization of clinical trial, ADR monitoring etc. CONCLUSION： There is risk in the drug clinical trial and it is necessary to