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. 2024 Apr 29:17:165-172.
doi: 10.2147/MDER.S457152. eCollection 2024.

Reporting of Demographics & Subgroup Analyses in Premarketing Studies of FDA Approved High-Risk Cardiovascular Devices, 2014-2022

Matthew J Swanson  1   2 , Colin L Uyeki  1 , Sarah R Yoder  1 , Sanket S Dhruva  3 , Jennifer E Miller  4 , Joseph S Ross  4   5   6
Affiliations

Reporting of Demographics & Subgroup Analyses in Premarketing Studies of FDA Approved High-Risk Cardiovascular Devices, 2014-2022

Matthew J Swanson et al. Med Devices (Auckl). .

Abstract

Background: Representation of diverse study populations in pivotal clinical trials for medical devices and subgroup analyses for demographic groups to explore differences in safety and effectiveness are essential to understanding the benefits and risks in diverse populations. The US Food and Drug Administration (FDA) has taken many steps to improve transparency and subgroup analyses over the past decade, but there has not been a recent evaluation of demographic reporting and subgroup analyses.

Methods: We reviewed all FDA Premarket Approvals for high-risk cardiovascular devices from 2014 to 2022, focusing on pivotal studies supporting device approval. We abstracted detailed demographic data about the age, sex, race, ethnicity, and socioeconomic position of study participants. We also assessed the presence and results of subgroup analyses to understand the safety and effectiveness of devices across trial populations.

Results: Analysis of 92 pivotal studies revealed that age and sex were reported in 96.7% of the studies, while race and ethnicity were reported in 71.7% and 58.7%, respectively. However, only 7.9% of studies explicitly detailed the participation of older adults (≥65 years) and no studies reported patients' socioeconomic position. Subgroup analyses by sex were conducted in 70.7% of studies, with 12.3% reporting significant differences. In contrast, analyses by race and ethnicity were performed in only 12.0% of the studies, with 9.1% reporting significant differences.

Conclusion: Approximately one-third of pivotal studies for high-risk cardiovascular devices approved by the FDA from 2014 to 2022 did not report the race of study participants, nearly 40% did not report ethnicity, and more than 90% did not report the participation of older adults (≥65 years). Subgroup analyses were infrequently conducted by age or race and ethnicity. There is a need for better trial demographic reporting and conduct of subgroup analyses in premarketing studies to ensure the safety and effectiveness of medical devices for all patients.

Keywords: FDA; cardiovascular device; clinical trial; diversity; equity; inclusion.

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Conflict of interest statement

Drs. Dhruva, Miller, and Ross currently receive research support through the University of California-San Francisco (Dhruva) and Yale University (Miller, Ross) from Arnold Ventures. Dr. Dhruva receives research funding from the Department of Veterans Affairs. Dr. Dhruva also reports having received, in the past 36 months, funding from the Food and Drug Administration, Greenwall Foundation, National Evaluation System for Health Technology Coordinating Center, and National Institute for Health Care Management. Dr. Dhruva further reports serving on the Medicare Evidence Development and Coverage Advisory Committee and Institute for Clinical and Economic Review California Technology Assessment Forum. Dr. Miller receives research support from the Food and Drug Administration for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program and Scientific American through Yale University. Dr. Miller is a Board Member for Bioethics International and Galatea Bio. Dr. Ross currently receives research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing, from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology (NEST), from the Food and Drug Administration for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938), from the Agency for Healthcare Research and Quality (R01HS022882), and from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R01HS025164, R01HL144644); in addition, Dr. Ross is an expert witness at the request of Relator’s attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc that was settled in September 2022. The authors report no other conflicts of interest in this work.

References

    1. National Academies of Sciences, Engineering, and Medicine. Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups. Washington, DC: The National Academies Press; 2022. doi:10.17226/26479 - DOI - PubMed
    1. Varma T, Wallach JD, Miller JE, et al. Reporting of study participant demographic characteristics and demographic representation in premarketing and postmarketing studies of novel cancer therapeutics [published correction appears in JAMA Netw Open. 2021 May 3;4(5):e2114399]. JAMA Network Open. 2021;4(4):e217063. doi:10.1001/jamanetworkopen.2021.7063 - DOI - PMC - PubMed
    1. Varma T, Jones CP, Oladele C, Miller J. Diversity in clinical research: public health and social justice imperatives. J Med Ethics. 2023;49(3):200–203. doi:10.1136/medethics-2021-108068 - DOI - PubMed
    1. Varma T, Mello M, Ross JS, Gross C, Miller J. Metrics, baseline scores, and a tool to improve sponsor performance on clinical trial diversity: retrospective cross sectional study. BMJ Med. 2023;2(1):e000395. doi:10.1136/bmjmed-2022-000395 - DOI - PMC - PubMed
    1. Downing NS, Shah ND, Neiman JH, Aminawung JA, Krumholz HM, Ross JS. Participation of the elderly, women, and minorities in pivotal trials supporting 2011–2013 U.S. Food and Drug Administration approvals. Trials. 2016;17(1):199. doi:10.1186/s13063-016-1322-4 - DOI - PMC - PubMed