All Times EDT
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).