Preliminary Study of Risk Management Mode of New Drug Clinical Trials in China

Abstract

Abstract: Objective To provide references for establishment and implementation of risk management in new drug clinical trials, from the perspectives of investigators. Methods General modes and constructions of risk management were analyzed, and regulations and principles for drug risk management in developed country were used for comprehensive references. Moreover, the present situation of drug risk management in clinical trial in China was discussed. Results and Conclusion Based on the preliminary exploration, we proposed the new risk management mode for clinical trials of new drugs suitable for China.

Key words: new drug clinical trials, risk management, risk management mode

CLC Number:

XUE Wei ,DONG Fan ,LI Ke-Xin. Preliminary Study of Risk Management Mode of New Drug Clinical Trials in China[J]. Chinese Journal of Pharmacovigilance, 2014, 11(8): 488-491.

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