Speaker
Susan S. Ellenberg, PhD
Professor of Biostatistics, Medical Ethics, and Health Policy
Perelman School of Medicine
University of Pennsylvania
Topic
Data and Safety Monitoring Boards for Trials of COVID-19 Vaccines: The Challenges
Keywords
COVID-19; Data Monitoring Committee (DMC); Data and Safety Monitoring Board (DSMB); Pandemic; Vaccine trials; Monitoring boundaries; Safety and efficacy; NIH
Key Points
- With COVID-19, everyone, globally, is an “affected community.” This brings a strong sense of urgency for DSMBs.
- Several COVID-19 vaccine candidates are studied under the NIH umbrella. A single DSMB, constituted in mid-2020, oversees all these COVID-19 trials and reports to that trial’s Oversight Group.
- Subgroup issues have been important in COVID-19 vaccine trials. The DSMB monitors carefully for representation of subgroups of interest in trial participants, including those over age 65, Black, Hispanic, and participants with comorbidities that may predispose them to more serious disease.
Discussion Themes
Has there been pressure to prematurely discontinue any of the COVID-19 vaccine trials?
How accurate is the post-vaccine data being collected—especially since these vaccines have only emergency use authorization?
What are your thoughts on future trial design if we have another pandemic?
See more COVID-19 resources for researchers and access other webinars in the COVID-19 Grand Rounds series on the Collaboratory’s COVID-19 resource page. Read more about data and safety monitoring in the Living Textbook.
Tags
#pctGR, @Collaboratory1