Dr. David S. Salsburg’s career has been an exceptional one. He was the first statistician to work in Pfizer, Inc., and later became the first statistician from the pharmaceutical industry to be elected as an ASA fellow. He played a vital role as a statistician in Pfizer, Inc. at a time when the drug approval process was developed. For his contributions, Dr. Salsburg was awarded the Career Achievement Award of the Biostatistics Section of the Pharmaceutical Research and Manufacturers of America in 1994, for “significant contributions to the advancement of biostatistics in the pharmaceutical industry”. Dr. Salsburg also managed to achieve something rare among scientists, which is to popularize his field of research and make it accessible and enjoyable to laypeople. Dr. Salsburg is possibly best known for his book “The Lady Tasting Tea – How Statistics Revolutionized the 20th Century Science”, in which he combines simple and engaging explanations of statistical methods, and why they are needed, along with personal stories told with a great deal of generosity, fondness, and humor about the people who developed them. Dr. Salsburg’s admiration for the those statisticians shines through. In this interview, Dr. Salsburg shares his own stories and perspectives, from his childhood, through his service in the Navy and his long and productive career in Pfizer, Inc. to his equally productive retirement, in which he authored “The Lady Tasting Tea” and other books.
Pub. online:4 Aug 2022Type:Research ArticleOpen Access
Journal:Journal of Data Science
Volume 18, Issue 3 (2020): Special issue: Data Science in Action in Response to the Outbreak of COVID-19, pp. 550–580
Abstract
The COVID-19 pandemic has triggered explosive activities in searching for cures, including vaccines against the SARS-CoV-2 infection. As of April 30, 2020, there are at least 102 COVID-19 vaccine development programs worldwide, the majority of which are in preclinical development phases, five are in phase I trial, and three are in phase I/II trial. Experts caution against rushing COVID-19 vaccine development, not only because the knowledge about SARS-CoV-2 is lacking (albeit rapidly accumulating), but also because vaccine development is a complex, lengthy process with its own rules and timelines. Clinical trials are critically important in vaccine development, usually starting from small-scale phase I trials and gradually moving to the next phases (II and III) after the primary objectives are met. This paper is intended to provide an overview on design considerations for vaccine clinical trials, with a special focus on COVID-19 vaccine development. Given the current pandemic paradigm and unique features of vaccine development, our recommendations from statistical design perspective for COVID-19 vaccine trials include: (1) novel trial design (e.g., master protocol) to expedite the simultaneous evaluation of multiple candidate vaccines or vaccine doses, (2) human challenge studies to accelerate clinical development, (3) adaptive design strategies (e.g., group sequential designs) for early termination due to futility, efficacy, and/or safety, (4) extensive modeling and simulation to characterize and establish long-term efficacy based on early-phase or short-term follow-up data, (5) safety evaluation as one of the primary focuses throughout all phases of clinical trials, (6) leveraging real-world data and evidence in vaccine trial design and analysis to establish vaccine effectiveness, and (7) global collaboration to form a joint development effort for more efficient use of resource and expertise and data sharing.