Inaugural COPSS-NISS Webinar on the Statistics of COVID-19 Vaccine Trials - ‘Standing Room Only’!

David Benkeser (Emory University) reviews the AstraZeneca clinical trial protocol.Presenter: David Benkeser, (Emory University), Moderator: Natalie Dean (University of Florida), Discussant: M. Elizabeth Halloran, (Fred Hutch and University of Washington)

How many people are interested in understanding and interpreting findings of the early results of COVID-19 vaccine efficacy trials?  Lots!  How many people can you get into a Zoom webinar?  More than you think!  Nearly 650 people logged into the Zoom webinar session that featured three distinguished individuals who are living in the thick of this research.  This session featured David Benkeser (Assistant Professor, Department of Biostatistics and Bioinformatics, Emory Rollins School of Public Health) as speaker, M. Elizabeth Halloran (Professor and Director, Biostatistics, Bioinformatics, and Epidemiology (BBE) Program, Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center and Professor, Department of Biostatistics, University of Washington) as discussant, and Natalie Dean (Assistant Professor, Department of Biostatistics, University of Florida) as moderator.

The session was opened by Xihong Lin (Harvard University), chair of the organizing committee for this new bi-weekly webinar series that aims to share the latest research regarding new understandings and analyses of COVID-19 pandemic data as a means to promote data-driven research and decision making to combat COVID-19.  This new series of webinars is co-organized by the Committee of the Presidents of Statistical Societies (COPSS) and its five charter member societies (ASAENARIMSSSC, and WNAR), as well as NISS.

Led by the remarks of David Benkeser (Emory University), this session took a deep dive into the design and analysis of COVID-19 vaccine trials, with a focus on Phase 3 efficacy trials.  David first walked through a quick overview of “Operation Warp Speed,” the accelerated vaccine development program.  Next, he focused on the current design protocols of the clinical trials taking place and the associated analysis of relative risk and relevant endpoints of these designs.  This led to a discussion of the results reported by Pfizer, Moderna and other clinical trials. In wrapping up his remarks, David emphasized the importance of vaccine correlates as they relate to identifying possible surrogate endpoints for future vaccine trials and understanding how these correlates might reliably predict vaccine efficacy in new populations who have thus far been excluded from research, such as children and pregnant women.

David’s presentation was followed by discussant Betz Halloran both on this topic generally and regarding points made by the speaker. She emphasized the huge amount of thought and effort that statisticians are putting into harmonizing trials, the exciting work that is being done with regards to correlates of risk and protection across platforms as well as mentioning the WHO’s Solidarity Trial platform that would involve several vaccines in a protocols that would share a placebo group.  Betz also stressed the importance of randomization and blinding and the issues that will likely arise, if the vaccines are highly effective, and involve these core principles of conducting trials.   She also raised the challenges of estimating the effect of the vaccines on reducing infectiousness.

Perhaps the most interesting part of the session was the reaction, interpretations and perspectives provided by both panelists and moderator Natalie Dean (University of Florida) who fielded questions posed by the attendees at the session.  Natalie certainly had her hands full!  Even with the considerable about of time given to Q&A, it became clear that there was not nearly enough time to answer all of the thought provoking questions that were posed.  But remember, this was only the first of many webinar sessions to come that will follow up on these and additional topics related to statistics and COVID-19.

Want to learn more?  Mark your calendar for every 1st and 3rd Thursday from noon to 1 pm ET.  (See the NISS website for event details and to register for these sessions!) 

Below, please find a recording of this session along with a link to the slides that the speaker used. The slides not only provide you with the key points that were offered but also include links to additional resources that should not be ignored!

Recording of the Session

Slides used by the Speakers

David Benkeser (Emory University)

At Warp Speed: Statistics and COVID-19 Vaccine Development


About this Webinar Series

The COPSS-NISS COVID-19 Data Science webinar series is co-organized by the Committee of the Presidents of Statistical Societies (COPSS) and its five charter member societies (ASAENARIMSSSC, and WNAR), as well as NISS.  This bi-monthly webinar features the latest research that is positioned on the cusp of new understanding and analysis of COVID-19 pandemic data, and promotes data-driven research and decision making to combat COVID-19.  Find out more about this series and view all the previous sessions on the Webinar Series page.

Friday, December 4, 2020 by Glenn Johnson