Risk and Management in Clinical Drug Trial / 中国药房

ABSTRACT

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 conduct risk management.