Common issues in safety analysis of clinical trail reports for new drugs of traditional Chinese medicine.
10.19540/j.cnki.cjcmm.20210407.501
- Author:
Na AN
1
;
Ling HAN
1
Author Information
1. Center for Drug Evaluation, National Medical Products Administration Beijing 100022, China.
- Publication Type:Journal Article
- Keywords:
clinical trail report;
common issues;
new drugs of traditional Chinese medicine;
safety analysis
- MeSH:
Clinical Trials as Topic;
Drugs, Chinese Herbal/adverse effects*;
Medicine, Chinese Traditional
- From:
China Journal of Chinese Materia Medica
2021;46(17):4581-4584
- CountryChina
- Language:Chinese
-
Abstract:
Clinical trail report is a summary of the process and results of clinical trail, an important basis to support the effectiveness and safety evaluation of drug marketing and an important technical data required for drug registration. Safety analysis is the main part and the most common issue of clinical trial report. In this article, it is summarized and analyzed the common problems found in the safety analysis part of the clinical trial report of new drugs of traditional Chinese medicine(TCM) in combination with the clinical professional evaluation of the application for marketing license of innovative TCM. The common problems in writing the safety aspects of clinical trail reports were summarized and analyzed, including the omissions of adverse events and laboratory test results, the failure to provide a detailed list of laboratory test outliers, the lack of professional depth in the analysis of the causal relationship between adverse events and TCM. In view of the common problems, it is suggested that the drug use degree, adverse events and adverse reactions, as well as laboratory examination should be considered. Check the three dimensions for necessary medical analysis, collation and summary and continuously improve the quality of safety analysis in clinical trial reports.
