ABSTRACT
Objective:The authenticity and accuracy of medical device related clinical trial data is crucial for the efficacy and safety of tested products. This article analyzed issues identified during previous data inspections of medical device clinical trials in our hospital, summarized experiences and findings, and proposed solutions.Methods:According to the " Medical Device Clinical Trial Inspection Points and Judgment Principles" , this study retrospectively analyzed the data inspection of medical device clinical trials in our hospital since 2016, summarized and analyzed the common issues identified.Results:A total number of six data inspections on medical device clinical trials were carried out in our hospital, during which 30 findings were identified. These findings include 4 items of pre-trial preparation, 2 items of patient rights protection, 7 items of trial processes, 12 items of records and reporting, as well as 5 items of experimental medical device management.Conclusions:The completeness, accuracy and consistency of clinical trial records in clinical trials of devices in our hospital have a lot space for improvement. And there is still room for improvement in the compliance to the protocol and the management of medical devices during the trial process. Based on the common findings, our drug clinical trial center will strengthen training and quality control, improve informatization and centralized management, and emphasize the importance of records. Through that the accuracy and authenticity of trial data for medical devices, and the credibility and objectiveness of trial results would be assured.
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.
Subject(s)
Clinical Trials as Topic , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Drugs, Chinese Herbal/adverse effectsABSTRACT
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.
