The NISS Ingram Olkin Forum on Unplanned Clinical Trial Disruptions

Abstract

CONTACT Nancy Flournoy flournoyn@missouri.edu Department of Statistics, University of Missouri (emerita), Columbia. The efforts arose from working groups formed during a NISS Ingram Olkin Forum series on the following topics: (1)Estimands and Missing Data, (2) The Role of Randomization Tests, (3) Methods to Cope with Information Loss and the Use of Auxiliary Sources of Data and (4) Bayes and Frequentist Approaches to Rescuing Disrupted Trials. These groups consider how existing methods can be applied in the context of unplanned clinical trial disruptions and uncover unsolved issues requiring further research. In addition to introducing you to these research projects, I am pleased to provide a brief introduction to the NISS Ingram Olkin Forums. The National Institute of Statistical Sciences (NISS) created Ingram Olkin Forums (IOFs) to foster Statistics Serving Society (S3) in memory of Professor Ingram Olkin. Motivated by the aspirations set forth by Olkin et al. (1990), each forum focuses on a current societal issue that might benefit from new or renewed attention from the statistical community. IOFs aim to bring the latest innovations in statistical methodology and data science into new research and public policy collaborations, working to accelerate the development of innovative approaches that impact societal problems. As a Forum brings a particular group of experts together for the first time to consider an issue, new energy and synergy is expected to produce a flurry of new ideas and approaches. The inaugural IOF was held in June 1919 on Gun Violence, prior to the arrival of the Covid-19 pandemic. Knowing that many statisticians would use their expertise to monitor the pandemic and to design vaccine and therapeutic trials, the IOF Committee looked for a need that might be neglected and decided to host an online IOF on Unplanned Clinical Trial Disruptions. A major concern in moving online was not to get stuck with one-directional webinars, but to get statisticians and other scientists who did not know each other previously to work together without meeting in-person. I am delighted to announce four papers resulting from this IOF will appear in Statistics in Biopharmaceutical Research. NISS is very happy with how well the IOF on Unplanned Clinical Trial Disruptions met its S3 objectives, with enthusiastic collegiality and productivity, and although in-person and hybrid launches will again be possible, this IOF is now NISS’s model.