Type I Error Considerations in Master Protocols With Common Control in Oncology Trials: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion

This article provides a summary of discussions from the American Statistical Association (ASA) Biopharmaceutical (BIOP) Section Open Forum organized by the ASA BIOP Statistical Methods in Oncology Scientific Working Group in coordination with the US FDA Oncology Center of Excellence on October 8, 2020. Diverse stakeholders including experts from international regulatory agencies, academicians, and members from the pharmaceutical industry engaged in a debate on Type I error considerations in master protocols with a common control. Although there were concerns in specific situations where Type I error adjustment may be necessary, the panelists agreed that adjustment of Type I error for multiplicity when a common control is used may not be necessary if the hypotheses are inferentially independent.