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Characteristics of the Multiplicity of Randomized Clinical Trials for Coronavirus Disease 2019 Launched During the Pandemic

Educational Objective
To understand the characteristics of the multiplicity of randomized clinical trials for COVID-19 launched during the pandemic

High-quality evidence generated by appropriately powered and controlled trials is needed to advance care for patients with coronavirus disease 2019 (COVID-19) and those who are susceptible to it.1,2 In the midst of the COVID-19 pandemic, multiple similar therapeutic trials are being conducted in parallel, potentially reducing participant accrual across trials. In this systematic review, we characterize the landscape of current COVID-19 trials to better quantify these potential issues.

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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.

Article Information

Accepted for Publication: June 15, 2020.

Published: July 13, 2020. doi:10.1001/jamanetworkopen.2020.15100

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2020 Kouzy R et al. JAMA Network Open.

Corresponding Authors: Ethan B. Ludmir, MD, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Unit 1422, Houston, TX 77030 (ebludmir@mdanderson.org); Cullen M. Taniguchi, MD, PhD, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Unit 1050, Houston, TX 77030 (ctaniguchi@mdanderson.org).

Author Contributions: Drs Kouzy and Ludmir had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Drs Kouzy and Abi Jaoude contributed equally as first authors. Drs Taniguchi and Ludmir contributed equally as senior authors.

Concept and design: Kouzy, Abi Jaoude, Taniguchi, Ludmir.

Acquisition, analysis, or interpretation of data: Kouzy, Abi Jaoude, Garcia Garcia, El Alam, Ludmir.

Drafting of the manuscript: Kouzy, Abi Jaoude, Garcia Garcia, Taniguchi, Ludmir.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Kouzy, Abi Jaoude, Garcia Garcia, El Alam, Ludmir.

Obtained funding: Abi Jaoude, Taniguchi.

Administrative, technical, or material support: Abi Jaoude, Taniguchi.

Supervision: Abi Jaoude, Taniguchi, Ludmir.

Conflict of Interest Disclosures: Ms Garcia Garcia reported receiving support from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health (NIH) (award number F31DK121384). Dr Taniguchi reported receiving supported from the NIH (award R01CA227517-01A1), Cancer Prevention & Research Institute of Texas (grant RR140012), V Foundation (grant V2015-22), the Kimmel Foundation, Sabin Family Foundation Fellowship, and the McNair Foundation and reported being a member of the clinical advisory board of Accuray outside the submitted work. No other disclosures were reported.

References
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Goodman  JL , Borio  L .  Finding effective treatments for COVID-19: scientific integrity and public confidence in a time of crisis.   JAMA. 2020;323(19):1899-1900. doi:10.1001/jama.2020.6434PubMedGoogle ScholarCrossref
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Kalil  AC .  Treating COVID-19: off-label drug use, compassionate use, and randomized clinical trials during pandemics.   JAMA. 2020;323(19):1897-1898. doi:10.1001/jama.2020.4742PubMedGoogle ScholarCrossref
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Moher  D , Liberati  A , Tetzlaff  J , Altman  DG ; PRISMA Group.  Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement.   Ann Intern Med. 2009;151(4):264-269. doi:10.7326/0003-4819-151-4-200908180-00135PubMedGoogle ScholarCrossref
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Prasad  V , Booth  CM .  Multiplicity in oncology randomised controlled trials: a threat to medical evidence?   Lancet Oncol. 2019;20(12):1638-1640. doi:10.1016/S1470-2045(19)30744-2PubMedGoogle ScholarCrossref
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Reuters. China trial of Gilead’s potential coronavirus treatment suspended. Published April 15, 2020. Accessed April 16, 2020. https://www.reuters.com/article/us-health-coronavirus-gilead-remdesivir/china-trial-of-gileads-potential-coronavirus-treatment-suspended-idUSKCN21X2A2
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London  AJ , Omotade  OO , Mello  MM , Keusch  GT .  Ethics of randomized trials in a public health emergency.   PLoS Negl Trop Dis. 2018;12(5):e0006313. doi:10.1371/journal.pntd.0006313PubMedGoogle Scholar
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