Joffe, Steven;
Babiker, Abdel;
Ellenberg, Susan S;
Fix, Alan;
Griffin, Marie R;
Hunsberger, Sally;
Kalil, Jorge;
... Whitley, Richard; + view all
(2021)
Data and Safety Monitoring of COVID-19 Vaccine Clinical Trials.
The Journal of Infectious Diseases
, 224
(12)
pp. 1995-2000.
10.1093/infdis/jiab263.
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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.
| Type: | Article |
|---|---|
| Title: | Data and Safety Monitoring of COVID-19 Vaccine Clinical Trials |
| Location: | United States |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1093/infdis/jiab263 |
| Publisher version: | https://doi.org/10.1093/infdis/jiab263 |
| Language: | English |
| Additional information: | This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions. |
| Keywords: | Science & Technology, Life Sciences & Biomedicine, Immunology, Infectious Diseases, Microbiology, SARS-CoV-2, COVID19, clinical trials, vaccines, data and safety monitoring |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10147724 |
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