Jan 23
Math/Stats Colloquium: Lianne Siegel, University of Minnesota
Tue, January 23, 2024
• 4:00pm
- 5:00pm (1h) • CMC 206
Title: Type I Error Control and Interim Monitoring for Co-Primary Hypotheses Involving a Subgroup
Abstract: The recent growth of immunoglobulin-based therapies has motivated clinical trials testing primary endpoints both in the overall cohort and in subgroups of patients, such as in patients without specific antibodies at baseline. Existing multiple correction methods in clinical trials often ignore the natural correlation between test statistics in such contexts, resulting in overly conservative type I error control. Motivated by OTAC, an ongoing Phase III trial evaluating the effect of a single infusion of anti-COVID-19 hyperimmune intravenous immunoglobulin (hIVIG), in outpatient adults with recently diagnosed SARS-CoV-2 infection, in both the overall cohort and in the subgroup of participants who had not received monoclonal antibodies or antiviral treatments, we propose a method to control the type I error at a predetermined rate while taking the estimated correlation into account, thus increasing efficiency. Extensive simulation studies indicate that the proposed method controls the type I error at the desired rate, improves power, and reduces the expected sample size compared to a Bonferroni correction.
Event Contact: Sue Jandro