Race-based reporting and participation of Black individuals in registered pain clinical trials, United States, 2000 to 2019 : PAIN

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Race-based reporting and participation of Black individuals in registered pain clinical trials, United States, 2000 to 2019

Vo, Anh Khoaa,b; Cerdeña, Jessica P.c; Loree, Jonathan M.d; Cairns, Brian E.a; Conklin, Annalijn I.a,e; Kaseweter, Kimberleyf; Chondoma, Leratog; Cragg, Jacquelyn J.a,b; Kramer, John L.K.h,*

Author Information

aFacutly of Pharmaceutical Sciences, University of British Columbia, Vancouver, BC, Canada

bInternational Collaboration on Repair Discoveries (ICORD), University of British Columbia, Vancouver, BC, Canada

cYale School of Medicine, Yale University, New Haven, CT, United States

dBC Cancer, Vancouver, BC, Canada

eCentre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, St. Paul's Hospital, Vancouver, BC, Canada

fBill Nelems Pain Research Centre, University of British Columbia, Okanagan Campus, Kelowna, BC, Canada

gIndigenous Research Support Initiative, VP Research and Innovation, University of British Columbia, Vancouver, BC, Canada

hDepartment of Anesthesiology, Pharmacology, and Therapeutics, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada

*Corresponding author. Address: International Collaboration in Repair Discoveries (ICORD), 818 W 10th Ave, Vancouver BC V5Z 1M9, Canada. E-mail address: [email protected] (J.L.K. Kramer).

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

PAIN 164(9):p 1976-1984, September 2023. | DOI: 10.1097/j.pain.0000000000002893

There are numerous, well-established racial disparities in the management of pain. The degree to which these are evident at the stage of conducting clinical trials is unknown. To address this knowledge gap, we examined race-based reporting, participation of Black individuals, and the factors associated with reporting and participation in pain clinical trials in the United States. Data were extracted from Clinicaltrials.gov and published articles. One thousand two hundred trials met our inclusion criteria; 482 (40.2%) reported participant race. More recent, publicly funded, and larger trials were more likely to report race. Of 82,468 participants included in pain clinical trials that reported race, 15,101 were Black individuals (18.3%). Participation of Black individuals was significantly associated with pain type (ß = +27% in cardiovascular disease pain compared with acute pain, P < 0.05), study population (ß = +33% and +7% in pain in minoritized populations and women, respectively, compared with general population, P < 0.05), pain intervention (ß = +7.5% for trials of opioid interventions compared with nonopioid interventions, P < 0.05), and a diverse team of investigators (ß = +8.0% for studies incorporating a visible non-White investigator compared with those that did not, P < 0.05). Our results indicate that representation of Black participants in pain clinical trials generally aligns with national demographics in the United States. Increased representation corresponds with health conditions more prevalent among Black individuals (eg, cardiovascular disease) and with a diverse study team composition. Despite these encouraging results, less than half of pain trials reported race, which introduces potential publication bias and limits external validity.

© 2023 International Association for the Study of Pain

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