4.7 Review

Data and Safety Monitoring of COVID-19 Vaccine Clinical Trials

Journal

JOURNAL OF INFECTIOUS DISEASES
Volume 224, Issue 12, Pages 1995-2000

Publisher

OXFORD UNIV PRESS INC
DOI: 10.1093/infdis/jiab263

Keywords

SARS-CoV-2; COVID19; clinical trials; vaccines; data and safety monitoring

Funding

  1. National Institute of Allergy and Infectious Diseases

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The US Federal Government has funded multiple phase 3 trials of COVID-19 vaccines and established a single DSMB to oversee and coordinate these trials, ensuring safety and shared insights. Challenges include the scale and pace of the trials, safety events related to a large number of participants, many of whom have underlying health risks, and the politicized environment in which the trials are conducted.
To speed the development of vaccines against SARS-CoV-2, the United States Federal Government has funded multiple phase 3 trials of candidate vaccines. A single 11-member data and safety monitoring board (DSMB) monitors all government-funded trials to ensure coordinated oversight, promote harmonized designs, and allow shared insights related to safety across trials. DSMB reviews encompass 3 domains: (1) the conduct of trials, including overall and subgroup accrual and data quality and completeness; (2) safety, including individual events of concern and comparisons by randomized group; and (3) interim analyses of efficacy when event-driven milestones are met. Challenges have included the scale and pace of the trials, the frequency of safety events related to the combined enrollment of over 100 000 participants, many of whom are older adults or have comorbid conditions that place them at independent risk of serious health events, and the politicized environment in which the trials have taken place.

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