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Abstract:
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In order to develop new drugs, it is necessary to enroll a sufficient number of patients in Phase 2b or Phase 3 in clinical trials. However, in the case of target diseases which are rare or for which enough information is not still obtained, it would be hard to estimate the appropriate sample size at designing clinical trials. Sample size re-estimation (SSR) has been proposed as a method to address those issues (c.f. FDA guideline: Adaptive Designs for Clinical Trials of Drugs and Biologics (2019)). As SSR is the method that sample size can be re-estimated during a trial by data available at that time, it is expected that SSR would have several advantages. However, there are not many clinical trials that SSR is used actually. From that, practically, it is thought that there are clinical trials that should have applied SSR to address problems which arise at designing clinical trials. In this presentation, we show the current situation of how often SSR is actually applied in clinical trials by using database (e.g. ClinicalTrials.gov) and summarize the conditions under which applying SSR can be considered.
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