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Pooling Data From Individual Clinical Trials in the COVID-19 Era

Educational Objective
To understand how to pool data from individual clinical trials during COVID-19
1 Credit CME

The rapid pace of the coronavirus disease 2019 (COVID-19) pandemic caused many research efforts to be initiated quickly. In some cases, nationally based platform trials have begun to report results.1 More frequently, however, randomized clinical trials (RCTs) were launched in local settings and in several cases missed the peak of the pandemic in their region. Now, some individual studies are at risk of failing to meet recruitment targets because of declining numbers of patients with COVID-19 who are being cared for at some participating sites.2 It may take several more COVID-19 surges to achieve full enrollment. Although the recent increase in COVID-19 cases reported in the US and several other countries offers the potential for enrollment in those regions, it is not certain that there will be sufficient number of centers ready with RCTs to address the pandemic in new hot spots. Launching RCTs in localities with currently increasing numbers of COVID-19 cases should be done; however, it is a time-consuming process and does not constitute a feasible short-term solution.

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Article Information

Corresponding Author: Elliott M. Antman, MD, Cardiovascular Division, Brigham and Women’s Hospital, 75 Francis St, Boston, MA 02115 (eantman@rics.bwh.harvard.edu).

Published Online: July 22, 2020. doi:10.1001/jama.2020.13042

Conflict of Interest Disclosures: Dr Petkova reports serving as statistician on the data and safety monitoring board (DSMB) of COVID-19 randomized clinical trials coordinated by NYU Langone Health. Dr Antman reports serving as chair of the DSMB for trials of therapies for COVID-19 that are being coordinated by NYU Langone Health. Dr Troxel reports serving as biostatistician for trials of therapies for COVID-19 that are being coordinated by NYU Langone Health.

Additional Contributions: We acknowledge the substantive contributions of Keith Goldfeld, DrPH, Mengling Liu, PhD, Arthur Caplan, PhD, and Judith Hochman, MD, all from NYU Grossman School of Medicine; and David DeMets, PhD, University of Wisconsin School of Medicine and Public Health. None of those acknowledged received any compensation for their contributions.

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