Journal article
Data and Safety Monitoring of COVID-19 Vaccine Clinical Trials
The Journal of infectious diseases, v 224(12), pp 1995-2000
15 Dec 2021
PMID: 34008027
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
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.
The federal government has empaneled a data and safety monitoring board to oversee the SARS-CoV-2 vaccine trials that it funds. We describe the DSMB’s mission and procedures and the challenges it has faced in overseeing these trials during a pandemic.
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Details
- Title
- Data and Safety Monitoring of COVID-19 Vaccine Clinical Trials
- Creators
- Steven Joffe - University of PennsylvaniaAbdel Babiker - Medical Research CouncilSusan S Ellenberg - University of PennsylvaniaAlan Fix - Program for Appropriate Technology in HealthMarie R Griffin - Vanderbilt HealthSally Hunsberger - National Institute of Allergy and Infectious DiseasesJorge Kalil - Hospital das Clínicas da Faculdade de Medicina da Universidade de São PauloMyron M Levine - University of Maryland, BaltimoreMalegapuru W Makgoba - , , , , , , , , , , , , , , , , , , , , , ,Reneé H Moore - Emory UniversityAnastasios A Tsiatis - North Carolina State UniversityRichard Whitley - University of Alabama at Birmingham
- Publication Details
- The Journal of infectious diseases, v 224(12), pp 1995-2000
- Publisher
- Oxford University Press
- Grant note
- ;
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Epidemiology and Biostatistics
- Web of Science ID
- WOS:000753487400002
- Scopus ID
- 2-s2.0-85119238678
- Other Identifier
- 991021448053804721
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InCites Highlights
Data related to this publication, from InCites Benchmarking & Analytics tool:
- Collaboration types
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Immunology
- Infectious Diseases
- Microbiology