The COVID-19 pandemic created a unique scientific dilemma for the science of understanding what therapies are beneficial, and whom do they benefit. The existing clinical trial science is way to slow and inefficient to get reliable answers in time to impact the global pandemic. Platform trials have provided an incredible response to the pandemic providing much needed, reliable, results on the therapeutic treatments for COVID-19. While the platforms have been incredibly successful in response to the pandemic they have also advanced clinical trial science. In this talk I will focus on the REMAP-CAP platform trial, and the scientific advances within the trial. These innovations include continual adaptive analyses, multifactorial randomization to patients, flexibility to add and subtract therapies as science evolves, response adaptive randomization, modeling of heterogeneous treatment effects, and applications of Bayesian statistics.
Bio: Scott Berry is President and a Senior Statistical Scientist at Berry Consultants, LLC. Since 2000, he has been involved in the design of hundreds of Bayesian adaptive clinical trials of pharmaceuticals and medical devices and has become an opinion leader in the field of Bayesian adaptive clinical trials. Some of these trials have been groundbreaking trial designs, setting new standards for innovation and flexibility in trial design. These include the trials supporting the first fully Bayesian approval by CDER of the United States FDA (Pravastatin-Aspirin combination) and the statistical design for Time Magazine’s #2 Medical Breakthrough of 2007 (Veridex’s GeneSearch BLN Assay), and an adaptive phase II/III seamless trial for Dulaglutide leading to FDA approval in September 2014. Recently he has been involved in the design of multiple adaptive platform trials for the treatment of COVID-19, including the REMAP-CAP COVID-19 platform trial, ACTIV-4a, and the mpRCT AARC.
He earned his PhD in statistics from Carnegie Mellon University and was an Assistant Professor at Texas A&M University before co-founding Berry Consultants in 2000. He is adjunct faculty in the Department of Biostatistics at the University of Kansas Medical Center. Dr. Berry was elected as a Fellow of the American Statistical Association in 2013.