The best laid plans... navigating uncertainty during COVID-19

Featuring Professor Stephen Senn, Dr Janet Wittes and Professor Frank Harrell

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Abstract: 'Clinical trials: Quo Vadis in the Age of COVID-19' By Prof. Stephen Senn

Abstract: 'Inference from an Ongoing Clinical Trial Affected by COVID-19 to the Post-COVID-19' By Dr. Janet Wittes

Abstract: Abstract: 'Sequential Bayesian Designs for Rapid Learning in COVID-19 Clinical Trials' By Prof. Frank Harrell

About the speakers:

Stephen Senn has worked as a statistician but also as an academic in various positions in Switzerland, Scotland, England and Luxembourg. From 2011-2018 he was head of the Competence Center for Methodology and Statistics at the Luxembourg Institute of Health. He is the author of Cross-over Trials in Clinical Research (1993, 2002), Statistical Issues in Drug Development (1997, 2007), Dicing with Death (2003). In 2009 was awarded the Bradford Hill Medal of the Royal Statistical Society. In 2017 he gave the Fisher Memorial Lecture. He is an honorary life member of PSI and ISCB.

Janet Wittes, PhD is President of WCG - Statistics Collaborative, Inc. Previously, she was Chief, Biostatistics Research Branch, National Heart, Lung, & Blood Institute (1983–89). The 2006 monograph, “Statistical Monitoring of Clinical Trials – A Unified Approach” by Proschan, Lan, and Wittes, deals with sequential trials. Her research has focused on design of randomized clinical trials, capture‑recapture methods in epidemiology, and sample size recalculation. She has served on a variety of advisory committees and data monitoring committees for government (NHLBI, the VA, NEI, and NCI) and industry. For the FDA, she has in the past been a member of the Circulatory Devices Advisory Panel and of the Cell and Gene Therapy Advisory Committee. She was formerly Editor in Chief of Controlled Clinical Trials (1994-98). From mid-February 2020 on, she has spent most of her time dealing with discussions about how to analyze data from clinical trials that were ongoing when the COVID-19 pandemic began.

Dr. Harrell received his PhD in Biostatistics from UNC in 1979. Since 2003 he has been Professor of Biostatistics, Vanderbilt University School of Medicine, and was the department chairman from 2003-2017. He is Expert Statistical Advisor for the Office of Biostatistics for FDA CDER. He is Associate Editor of Statistics in Medicine, and a member of the Scientific Advisory Board for Science Translational Medicine. He is a Fellow of the American Statistical Association and winner of the Association's WJ Dixon Award for Excellence in Statistical Consulting for 2014. His specialties are development of accurate prognostic and diagnostic models, model validation, clinical trials, observational clinical research, cardiovascular research, technology evaluation, pharmaceutical safety, Bayesian methods, quantifying predictive accuracy, missing data imputation, and statistical graphics and reporting.

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