دورية أكاديمية

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

التفاصيل البيبلوغرافية
العنوان: Reporting of Demographics & Subgroup Analyses in Premarketing Studies of FDA Approved High-Risk Cardiovascular Devices, 2014–2022
المؤلفون: Swanson MJ, Uyeki CL, Yoder SR, Dhruva SS, Miller JE, Ross JS
المصدر: Medical Devices: Evidence and Research, Vol Volume 17, Pp 165-172 (2024)
بيانات النشر: Dove Medical Press, 2024.
سنة النشر: 2024
المجموعة: LCC:Medical technology
مصطلحات موضوعية: fda, clinical trial, cardiovascular device, diversity, inclusion, equity, Medical technology, R855-855.5
الوصف: Matthew J Swanson,1,2 Colin L Uyeki,1 Sarah R Yoder,1 Sanket S Dhruva,3 Jennifer E Miller,4 Joseph S Ross4– 6 1Frank H. Netter MD School of Medicine, Quinnipiac University, North Haven, CT, USA; 2Leonard N. Stern School of Business, New York University, New York, NY, USA; 3Department of Medicine, University of California, San Francisco School of Medicine, San Francisco, CA, USA; 4Department of Medicine, Yale School of Medicine, New Haven, CT, USA; 5Department of Health Policy and Management, Yale School of Public Health, New Haven, CT, USA; 6Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USACorrespondence: Matthew J Swanson, Frank H. Netter MD School of Medicine, Quinnipiac University, 370 Bassett Road, North Haven, CT, 06473-1908, USA, Email Matthew.Swanson@stern.nyu.eduBackground: 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, clinical trial, cardiovascular device, diversity, inclusion, equity
نوع الوثيقة: article
وصف الملف: electronic resource
اللغة: English
تدمد: 1179-1470
Relation: https://www.dovepress.com/reporting-of-demographics--subgroup-analyses-in-premarketing-studies-o-peer-reviewed-fulltext-article-MDER; https://doaj.org/toc/1179-1470
URL الوصول: https://doaj.org/article/d14f27cb4b5d4aad8e451f9134c8ccbb
رقم الأكسشن: edsdoj.14f27cb4b5d4aad8e451f9134c8ccbb
قاعدة البيانات: Directory of Open Access Journals