In clinical trials of drug/medical device research and development,especially in clinical trials of anti-tumor drugs,some-times the main endpoints are evaluated by images.When image-related endpoints are used as the main study endpoint in clinical trials,in order to ensure the objectivity and stability of the evaluation,the Independent Review Committee(IRC)is usually set up in clinical research,that is,the"independent image evaluation".IRC uses standardized image evaluation procedures to provide image protocol standardization,improve data quality,reduce bias and variability,and provide support for regulatory approval,which plays an important role in clinical trials.The scope of IRC's application mainly includes safety evaluation,efficacy/effectiveness evaluation,imaging data,pathological data and photo data.IRC can improve the objectivity and reliability of image evaluation,help develope new drugs,and thus bring more benefits to the pharmaceutical industry.On the basis of sorting out the history of IRC's development,this study briefly describes the relevant guidance requirements of the regulatory agencies on setting and running IRC,analyzes the value of IRC for the research and development of drugs/medical devices,and summarizes the work content,applicable scenarios and commonly used evalua-tion criterias of IRC,and the future development trend of IRC,with the aim to provide experience and reference for more new drug research and development.
关键词
独立评审委员会(IRC)/新药研发/疗效评估/临床试验
Key words
Independent Review Committee(IRC)/New drug research and development/Evaluation of efficacy/Clinical trial
维普
万方数据