Reporting of participant race and ethnicity from COVID-19 randomized controlled drug and biologicals trials: a scoping review
- Shelly Melissa Pranić 1,2, Maria Dulce Estevão 3, Lenny T Vasanthan 4, Iván Pérez-Neri 5, Anika Pulumati 6, Fábio Antonio Serra de Lima Junior 7, Narges Malih 8,9, Vinayak Mishra 10, Jacqueline Thompson 11, Daniel Nnate 10
- 1Department of Public Health, University of Split School of Medicine, 21000 Split, Croatia.
- 2Cochrane Croatia, 21000 Split, Croatia.
- 3School of Health, University of Algarve, Faro, Faro District, 8005-139, Portugal.
- 4Physiotherapy Unit, Physical Medicine and Rehabilitation Department, Christian Medical College, Vellore, 632004, India.
- 5Department of Neurochemistry, National Institute of Neurology and Neurosurgery Manuel Velasco Suárez, Insurgentes Sur 3877, La Fama, Tlalpan, 14269, Ciudad de México, Mexico.
- 6University of Missouri-Kansas City School of Medicine, Kansas City, MO, United States.
- 7Centro de Ciências Médicas, Universidade Federal da Paraíba (Federal University of Paraíba), João Pessoa, Castelo Branco, PB, 58051-900, Brazil.
- 8Global Health Research Group, University of the Balearic Islands, 07122 Palma, Spain.
- 9Social Determinants of Health Research Center, Shahid Beheshti University of Medical Sciences, 1983969411 Tehran, Iran.
- 10University of Liverpool, Liverpool, L69 7ZX, United Kingdom.
- 11University of Birmingham, Edgbaston, Birmingham, B15 2TT, United Kingdom.
- 0Department of Public Health, University of Split School of Medicine, 21000 Split, Croatia.
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View abstract on PubMed
Summary
This summary is machine-generated.Most COVID-19 drug trials reported race and ethnicity, but participation varied. Researchers must address factors limiting minority involvement in clinical trials to ensure equitable data.
Area Of Science
- Clinical Trials
- Health Disparities
- COVID-19 Research
Background
- Racial and ethnic minorities experienced disproportionate COVID-19 hospitalization and death.
- Understanding demographic representation in clinical trials is crucial for equitable research.
- COVID-19 drug randomized controlled trials (RCTs) are key to evaluating effective treatments.
Purpose Of The Study
- To assess the frequency of reported race and ethnicity in COVID-19 drug RCTs.
- To examine how race and ethnicity reporting correlates with trial characteristics.
- To identify trends in participation across different racial and ethnic groups.
Main Methods
- Scoping review of RCTs for approved COVID-19 drugs (remdesivir, baricitinib, molnupiravir).
- Searches conducted across major databases (PubMed, Cochrane) and preprint servers (Jan 2020-May 2022).
- Data extraction included demographic variables (race, ethnicity), study design, and participant outcomes.
Main Results
- 17 RCTs (17,935 participants) were included; 76% reported race/ethnicity and were US-based, industry-funded.
- Asian, Black, Latinx, and White participants were most common in remdesivir trials.
- Outcome assessment varied by race/ethnicity: Native American/Hawaiian in ventilation trials, Black/White in recovery trials, Asian/Latinx/multirace in hospitalization/death trials.
Conclusions
- While most trials reported demographics, participation varied significantly across racial and ethnic groups.
- Study-level factors in COVID-19 drug RCTs may influence minority participation.
- Future research should focus on increasing minority representation to inform equitable interventions.
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