Analysis and Case Study of the Clinical Trial Design for the Antitumor Drug Companion Diagnostic Devices
Objective:To systematically elucidate the principles of clinical trial design of the companion diagnostic devices(CDx)in our country,and to provide references for the clinical trials of related CDx.Methods:Based on the different development models of CDx,the clinical trial designs of the original and non-original CDx developed simultaneously with anti-tumor drugs in China were introduced.Combined with the considerations during the relevant product technical review,the science and rationality of the clinical trials design of CDx were analyzed in depth.Results and Conclusion:The CDx plays a very important role in the clinical application of the anti-tumor drugs.The clinical trials of the CDx and the clinical trials of anti-tumor drugs are closely related.There are multiple types of designs for clinical trials of this kind of products.Clinical trial main investigators should choose the appropriate clinical trial designs based on the specific conditions of product development mode and product detection markers,which could evaluate the clinical significance of the product more scientifically and reasonably,and promote the product to market as soon as possible.
companion diagnostic devices(CDx)development modelsclinical trial designbridge studycase study analysis
NETL
NSTL
万方数据
维普
