October 21, 2021 Webinar
Issues in Confirmatory Clinical Trial Design for Cancer Immunotherapies
Keaven Anderson, PhD
Abstract
We discuss approaches to designing group sequential clinical trials for immunotherapies to help maximize the chance of success. Immunotherapy may not provide efficacy early either due to a delay in treatment effect or to a possibly unidentified (biomarker) subgroup where treatment is less effective. Often the strongest treatment effect for immunotherapies is for overall survival.Thus, trials may evaluate multiple endpoints in multiple populations at multiple points in time during the course of the trial. In addition to this large multiple testing issue, standard methods assuming proportional hazards are likely inefficient for detecting a treatment benefit. Despite all of these challenges, many trials have proven successful.We discuss testing of multiple endpoints in group sequential design and related issues such as graphical multiplicity, non-proportional hazards, spending approaches, and correlations between tests of different hypotheses.
Short Bio
Keaven Anderson is an Associate Scientific VP of Methodology Research in Biostatistics at Merck. He has decades of experience in the pharmaceutical industry working on clinical trials plus previous experience in epidemiology at the Framingham Heart Study. Keaven is a Fellow of the ASA. He has long-standing interests in survival analysis, group sequential design and multiplicity. A current interest is to support the use of open source R software for regulatory purposes.