Office of Orthopedic Devices, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
Office of Clinical Evidence and Analysis, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
J Bone Joint Surg Am. 2024 Nov 6;106(21):2009-2016. doi: 10.2106/JBJS.24.00201. Epub 2024 Sep 12.
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.
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.
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.
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.
在美国食品和药物管理局（FDA），设备和放射健康中心（CDRH）的使命是确保所有患者和提供者都能及时、持续地获得安全、有效和高质量的医疗设备和安全的放射产品。尽管 CDRH 已经观察到某些临床试验的入组差异，但据我们所知，尚未对基线人口统计学方面的入组差异进行系统分析。
CDRH 从 1985 年至 2020 年，对所有已授权的涉及骨科临床研究的医疗器械的公开文件中，总结了研究参与者及其基线人口统计学信息。进行了描述性分析和探索性统计检验，以分别调查报告的性别和种族百分比与美国国家人口普查和美国关节置换登记处（AJRR）报告的百分比进行比较。
我们从 261 个原始临床研究臂中的 94 个提交内容和相应的综合临床试验中确定了 34193 名参与者。大多数提交内容报告了年龄和性别，而只有 36 个提交内容（38.3%）报告了种族人口统计学信息。在提供性别入组信息的 88 项试验中，女性入组百分比范围为 22.2%至 88.7%，平均值为 55.0%。在报告种族数据的提交内容（38.3%）中，白人患者和黑人患者的平均入组率分别为 89.2%（范围为 64.8%至 98.7%）和 6.2%（范围为 0.4%至 20.7%）。其他少数族裔群体的入组率范围为 0%至 3.0%。这些临床试验显示女性代表性（55.0%）数值较低，但白人代表性（89.2%）较高，与 AJRR 报告的情况相比。其他种族群体的参与度远低于其在美国人口中的相应比例，但在 AJRR 中也有类似的代表性。
支持 FDA 授权骨科设备的临床试验有广泛的性别和种族入组范围。女性入组似乎反映了美国人口中女性的比例。然而，尽管此前已经做出努力，但一些种族群体仍然代表性不足。FDA 已承诺将推进健康公平作为 CDRH 2022-2025 年战略重点的一部分。我们希望本研究的结果将有助于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。
