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Public reporting of black participation in anti-hypertensive drug clinical trials - 14/03/23

Doi : 10.1016/j.ahj.2023.01.001 
Michael D. Green, BA a, f, , Mahalia R. Dalmage, BA b, Jay B. Lusk, BSC c, d, Emilie F. Kadhim, MPH, BA e, Lesley A. Skalla, PhD, MSLS f, Emily C. O'Brien, PhD a
a Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, United States of America 
b Division of Biological Sciences, Pritzker School of Medicine, University of Chicago, Chicago, IL, United States of America 
c Department of Neurology, Duke University School of Medicine, Durham, NC, United States of America 
d Fuqua School of Business, Duke University, Durham, NC, United States of America 
e Social & Behavioural Health Sciences Division, Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada 
f Duke University Medical Center Library & Archives, Duke University School of Medicine, Durham, NC, United States of America 

Reprint requests: Michael D. Green, BA, Duke University School of Medicine, 215 Morris Street, Durham NC 27701.Duke University School of Medicine215 Morris StreetDurhamNC27701

Riassunto

Background

Non-Hispanic Black people in the United States have the highest prevalence of essential hypertension. Unfortunately, clinical trials often underrepresent Black patients. We aim to understand whether trial sponsorship type is associated with representation of Black participants in anti-hypertensive drug clinical trials. Then, we contextualize our findings amongst current efforts to improve diversity in clinical research populations.

Methods

We searched ClinicalTrials.gov in May 2022 for antihypertensive drug trials. Of n = 408 trials in our initial search, n = 97 (23.77%) met inclusion criteria and were stratified by sponsorship type (industry vs non-industry). Standardized tests of difference were employed to compare characteristics of these trials, and linear regression was used to model change over time.

Results

Of 97 trials reporting results from 2010 to 2020, there were minimal differences in the percent of Black patients enrolled in anti-hypertensive clinical trials by sponsorship type. Both industry and non-industry sponsored studies had high rates of non-reporting, with slightly more non-reporting for industry (73.2%) vs non-industry (66.67%) studies. Industry funded studies reported results to ClinicalTrials.gov within 23.3 ± 15.0 months from completing studies, while non-industry funded trials reported within 18.9 ± 10.8 months.

Conclusions

Despite Black Americans carrying the highest burden of disease for essential hypertension, they are underrepresented in anti-hypertension clinical trials and their overall participation has decreased between 2010 and 2020. In addition, there is major underreporting of trial participant race. We implore researchers and funders to establish clear, meaningful targets for anti-hypertensive drug trial diversity, and improve transparency in reporting of study characteristics.

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Vol 258

P. 129-139 - Aprile 2023 Ritorno al numero
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