Thirty-five Years of Reporting of Sex and Race in Clinical Studies of U.S. FDA-Authorized Orthopaedic Devices.

Hongying Jiang,Katherine Kavlock,Qin Li,Shruti Mistry,Valerie Hermes,Alonza Gibbs,Elizabeth Adegboyega-Panox,Raquel Peat
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Abstract

BACKGROUND At the U.S. Food and Drug Administration (FDA), the mission of the Center for Devices and Radiological Health (CDRH) is to ensure that all patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. Although the CDRH has observed enrollment differences in some clinical trials, no systematic analysis has been conducted regarding enrollment differences in baseline demographics, to our knowledge. METHODS The CDRH has summarized information on study participants and their baseline demographics in public-facing documentation for all authorized medical devices that involved orthopaedic clinical studies from 1985 to 2020. Descriptive analyses and exploratory statistical testing have been conducted to investigate the reported percentages by sex and race compared with those reported in the U.S. National Census and the American Joint Replacement Registry (AJRR), respectively. RESULTS We identified 94 submissions and corresponding combined clinical trials from 261 original clinical study arms with 34,193 participants. Most of the submissions reported age and sex, while only 36 submissions (38.3%) reported racial demographics. Among the 88 trials providing enrollment by sex, the female enrollment percentage ranged from 22.2% to 88.7%, with a mean of 55.0%. In the submissions that reported racial data (38.3%), White and Black patients had a mean enrollment of 89.2% (range, 64.8% to 98.7%) and 6.2% (range, 0.4% to 20.7%), respectively. The enrollment for other minority groups ranged from 0% to 3.0%. These clinical trials have shown numerically lower female representation (55.0%) but higher White representation (89.2%) than what has been reported in the AJRR. The other racial groups have participated much less than their corresponding percentages in the U.S. population, but they are similarly represented in the AJRR. CONCLUSIONS The clinical trials supporting the FDA's authorization of orthopaedic devices had a wide range of sex and racial enrollments. It appears that female enrollment mirrors the percentage of women in the U.S. population. However, despite prior efforts, some racial groups are still underrepresented. The FDA has made a commitment to advancing health equity as part of the 2022-2025 Strategic Priorities of the CDRH. We hope that the results of this study will help health-care professionals make informed clinical decisions when using medical devices.
美国 FDA 批准的矫形器临床研究中的性别和种族报告三十五年》(Thirty-five Years of Reporting of Sex and Race in Clinical Studies of U.S. FDA-Authorized Orthopaedic Devices)。
背景在美国食品和药物管理局(FDA),器械和放射卫生中心(CDRH)的使命是确保所有患者和医疗服务提供者都能及时、持续地获得安全、有效、高质量的医疗器械和安全的放射产品。据我们所知,虽然 CDRH 在一些临床试验中观察到了入组差异,但还没有对基线人口统计学方面的入组差异进行过系统分析。方法CDRH 在面向公众的文件中汇总了 1985 年至 2020 年期间涉及骨科临床研究的所有授权医疗器械的研究参与者及其基线人口统计学信息。我们进行了描述性分析和探索性统计检验,以调查报告的性别和种族百分比与美国全国人口普查和美国关节置换注册表(AJRR)中报告的百分比的比较。大多数试验报告了年龄和性别,只有 36 项试验(38.3%)报告了种族人口统计数据。在 88 项提供性别注册人数的试验中,女性注册人数的比例从 22.2% 到 88.7% 不等,平均比例为 55.0%。在报告种族数据(38.3%)的呈文中,白人和黑人患者的平均入组比例分别为 89.2%(范围为 64.8% 到 98.7%)和 6.2%(范围为 0.4% 到 20.7%)。其他少数族裔群体的注册率从 0% 到 3.0% 不等。与 AJRR 的报告相比,这些临床试验中女性的比例较低(55.0%),但白人的比例较高(89.2%)。结论:支持 FDA 批准矫形设备的临床试验在性别和种族方面的注册人数范围很广。女性注册人数似乎反映了美国人口中女性的比例。然而,尽管此前做出了努力,但一些种族群体的代表性仍然不足。作为 2022-2025 年 CDRH 战略重点的一部分,FDA 已承诺推进健康公平。我们希望这项研究的结果能帮助医疗保健专业人员在使用医疗器械时做出明智的临床决策。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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