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Infectious Diseases

Geographical Representation of Low- and Middle-Income Countries in Randomized Clinical Trials for COVID-19

Educational Objective
To identify the key insights or developments described in this article

1 Credit CME

JAMA Network Open

Published Online: February 25, 2022

Research Letter

Article Information and Disclosures

Mahesh Ramanan, MMed¹;

Steven Y. C. Tong, MBBS, PhD²;

Aashish Kumar, MBBS³;

Balasubramanian Venkatesh, MD¹

Author Affiliations

¹Critical Care Division, The George Institute for Global Health, University of New South Wales, Sydney, Australia
²Department of Infectious Diseases, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia
³Logan Hospital, Meadowbrook, Australia

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COVID-19 has had a major impact on all countries and regions globally. The populations where randomized clinical trials (RCTs) have been conducted may not reflect the burden of disease.¹^,2

In this systematic review, we evaluated the proportion of participants recruited in RCTs for COVID-19 from low- and middle-income (LMIC) countries compared with high-income countries (HIC) (using World Bank definitions) relative to disease burden in these regions. We also examined these proportions stratified by COVID-19 vaccine and nonvaccine RCTs. We followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline.

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Article Information

Accepted for Publication: January 07, 2021.

Published: February 25, 2022. doi:10.1001/jamanetworkopen.2022.0444

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2022 Ramanan M et al. JAMA Network Open.

Corresponding Author: Steven Y. C. Tong MBBS, PhD, Department of Infectious Diseases, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, 792 Elizabeth St, Melbourne, VIC, Australia (steven.tong@mh.org.au).

Author Contributions: Drs Ramanan and Tong 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.

Concept and design: Ramanan, Tong, Venkatesh.

Acquisition, analysis, or interpretation of data: Ramanan, Tong, Kumar.

Drafting of the manuscript: Ramanan, Tong, Venkatesh.

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

Statistical analysis: Ramanan.

Administrative, technical, or material support: Ramanan.

Supervision: Tong, Venkatesh.

Conflict of Interest Disclosures: Dr Tong reported receiving grants from the National Health and Medical Research Council Career Development Fellowship during the conduct of the study. Dr Venkatesh reported receiving institutional research support from Baxter Health Care outside the submitted work; and an Investigator Fellowship from the National Health and Medical Research Council, Australia. No other disclosures were reported.

AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
1.00 credit toward the CME of the American Board of Surgery’s Continuous Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.