Discussion on the issues and solutions in clinical trial design of new traditional Chinese medicines from the perspective of quality control
A scientific,standardized,and feasible trial design is the basis for obtaining reliable data and guaranteeing the quality of clinical trials.In this study,the authors gathered and organized the information of clinical trials of registered traditional Chinese medicines varieties undertaken by a drug clinical trial institution,summarized and analyzed the issues in the clinical trial design.The issues found in the review of 18 clinical trials of traditional Chinese medicine were summarized and classified into six categories:non-compliance with regulatory requirements,unclear description of protocol content,poor feasibility of design of clinical trial documents such as trial protocol and case report form,inconsistent operation requirements before and after different research documents or the same document,writing errors,and others.In view of the above problems,the authors put forward the countermeasures that can be taken by the sponsor,investigator,and clinical trial institution to ensure the quality of the design,in order to provide reference for improving the quality of clinical trials.
clinical trialnew traditional Chinese medicinequality controlexperimental design
NETL
NSTL
万方数据
