PSI Webinar: Subgroup Analysis

  • Dates: 01 – 01 Oct, 2019
2:00pm to 5:00pm

Following the workshop discussing the EMA draft guideline on the investigation of subgroups in confirmatory clinical trials, an EFSPI/PSI Special Interest Group has been exploring methods which could be used within the framework of such guidance.  These approaches have also been discussed with European regulatory statisticians. 

The main focus of this webinar will be to provide a summary of the key methods recommended by the SIG, presented by Aaron Dane, along with some perspective on the proposed methods provided by Rob Hemmings given his experiences as a European regulatory reviewer.  David Svensson will also outline the future direction and research planned for the EFSPI/PSI SIG, which will be followed by a discussion of the approaches and regulatory perspectives presented.

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