Discussions on the standardized safety evaluation of new drugs in phase I clinical trials
10.13699/j.cnki.1001-6821.2014.10.029
- VernacularTitle:Ⅰ期新药临床试验中安全性数据规范化分析探讨
- Author:
Min-Ji WEI
1
;
Shui-Qiang WANG
;
Cai-Yun ZHAO
;
Xu-Guang GUO
Author Information
1. 北京大学 第一医院 临床药理研究所
- Keywords:
phase I clinical trial;
safety evaluation;
standardization;
drug safety;
adverse event
- From:
The Chinese Journal of Clinical Pharmacology
2014;(10):966-969
- CountryChina
- Language:Chinese
-
Abstract:
The strategies for pushing phase Ⅰ new drug clinical trials for-ward are based on the ratio of benefit to risk.Thus it would be a good starting to perform a standardized safety evaluation when a new drug enters its early phase trial.In the present paper, we evaluated the safety information contained in the phase I clinical study reports of new drugs and found improvements needed to be done in the following areas , such as the standard terminology used for adverse events , presentation of adverse events, classification of laboratory parameters and special atten -tions to the important and unexpected adverse events , etc.Finally, we proposed to adopt a standardized practice based on Technical Requirements for Registration of Pharmaceuticals for Human Use of International Confer -ence on Harmonization(ICH) guidelines in the assessment of drug safety.
