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All Times EDT

Thursday, September 24
Thu, Sep 24, 1:30 PM - 2:45 PM
Virtual
Historical Data Borrowing in Clinical Trials

A Two-Stage Study Design Framework for Utilizing External Data to Augment a Clinical Trial (301180)

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Wei-chen Chen, FDA/CDRH 
Heng Li, FDA/CDRH 
Nelson Lu, FDA/CDRH 
Ram Tiwari, FDA/CDRH 
Chenguang Wang, John Hopkins University 
*Yunling Xu, FDA/CDRH 
Lilly Yue, Food and Drug Administration  

Keywords: RCT, external Data, covariate balance, 2-stage study design

In this presentation, we discuss a two-stage study design framework to better ensure validity and maintain integrity of the trial for augmenting a clinical trial utilizing external data. The two-stage study design framework is tailored to confirmative purpose emphasizing sequential access of data, and it covers selection of patients from historical studies /registries and assessment of similarity in patient characteristics between the current study and the historical/external data source(s).