Limitations of the Safety Assessment in Premarketing Clinical Trials of Drugs and Suggestions for Improvement

doi:10.19803/j.1672-8629.2020.08.04

Abstract

Abstract: Objective To offer recommendations for sponsors on how to assess the safety of premarketing drugs more comprehensively, in more depth and scientifically by outlining the limitations of safety assessment in premarketing clinical trials of drugs. Methods The related literature abroad, guidelines and group recommendations related to the safety assessment in premarketing clinical trials of drugs were collected, while the representative opinions, views and suggestions in these documents were summarized and analyzed. Results The current ways of safety assessment in premarketing clinical trials of drugs have some weaknesses, such as an insufficient number and composition of subjects, inaccurate coding of adverse events, neglect of exposure time, and difficulty in determining causal relationships. Conclusion It is suggested that sponsors should do what they can to improve the design of safety assessment in premarketing clinical trials of drugs, collect as much safety information as possible, evaluate drug exposure time properly, use data visualization appropriately, analyze safety data in depth and make full use of safety evidence.

Key words: premarketing assessment, drug clinical trials, safety, adverse events, limitation, suggestion

CLC Number:

LI Xinxu, TANG Zhimin, ZHOU Jun, WANG Jun. Limitations of the Safety Assessment in Premarketing Clinical Trials of Drugs and Suggestions for Improvement[J]. Chinese Journal of Pharmacovigilance, 2020, 17(8): 465-470.

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