Data and Safety Monitoring of COVID-19 Vaccine Clinical Trials | Zendy

Steven Joffe | Zendy; Abdel G. Babiker | Zendy; Susan S. Ellenberg | Zendy; Alan Fix | Zendy; Marie R. Griffin | Zendy; Sally Hunsberger | Zendy; Jorge Kalil | Zendy; Myron M. Levine | Zendy; Malegapuru W. Makgoba | Zendy; Reneé H. Moore | Zendy; Anastasios A. Tsiatis | Zendy; Richard J. Whitley | Zendy

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Data and Safety Monitoring of COVID-19 Vaccine Clinical Trials

Author(s) -

Steven Joffe,

Abdel G. Babiker,

Susan S. Ellenberg,

Alan Fix,

Marie R. Griffin,

Sally Hunsberger,

Jorge Kalil,

Myron M. Levine,

Malegapuru W. Makgoba,

Reneé H. Moore,

Anastasios A. Tsiatis,

Richard J. Whitley

Publication year - 2021

Publication title -

the journal of infectious diseases

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 2.69

H-Index - 252

eISSN - 1537-6613

pISSN - 0022-1899

DOI - 10.1093/infdis/jiab263

Subject(s) - interim , data monitoring committee , clinical trial , interim analysis , accrual , safety monitoring , medicine , pace , government (linguistics) , covid-19 , family medicine , environmental health , business , infectious disease (medical specialty) , disease , political science , bioinformatics , geography , accounting , linguistics , philosophy , earnings , geodesy , law , biology

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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