Risk Identification and Evaluation of Clinical Trials of I nnovative Drugs under New Policy Environment
- VernacularTitle:新政策环境下创新药物临床试验风险识别及评估
- Author:
Xiaoling AN
1
;
Wenqiang HUANG
1
;
Yunan SU
1
;
Zhen LUO
1
Author Information
1. School of Pharmacy，Lanzhou University，Lanzhou 730030，China
- Publication Type:Journal Article
- Keywords:
Clinical trials of innovative drugs;
New policy environment;
Principal component analysis;
Risk identification
- From:
China Pharmacy
2021;32(10):1153-1157
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE：To identify and evaluate the risk factors of innovative drug clinical trials ，and to provide references for the development of risk management and control strategies. METHODS ：Using the method of literature research ，the risk factors of innovative drug clinical trials were obtained ，classified and sorted out ，and the risk evaluation indicators were initially formed. On this basis ，the questionnaire was designed. By means of interview and questionnaire survey ，54 experts were invited from 4 tertiary hospitals and 1 contract research organization to score. SPSS 24.0 software was used to perform principal component analysis on risk event status data. RESULTS & CONCLUSIONS ：The risk evaluation system included 9 first-class indicators such as policy and legal risk ，clinical trial institution risk and trial scheme design risk ，and 31 second-class indicators such as industrial policy，law and regulation changes ，intellectual property risk . According to the analysis ，the risk factors of innovative drug clinical trials mainly included drug and biological sample management risk ，trial scheme design risk ，clinical trial institution risk ，safety report management risk ，ethical review risk ，policy and legal risk ，and subject management risk. Relevant parties in clinical trials need to focus on monitoring various risk factors ，establish dynamic monitoring and control mechanism and implementation guarantee mechanism ，and effectively prevent and control risk ，to promote the smooth implementation of clinical trials.
