Department of Clinical Research & Leadership, School of Medicine and Health Sciences, The George Washington University, Washington, DC, USA.
School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.
J Natl Med Assoc. 2023 Aug;115(4):454-458. doi: 10.1016/j.jnma.2023.06.008. Epub 2023 Jul 4.
The need for diverse representation in clinical trials has recently been reinforced by the Food and Drug Administration's (FDA) guidance for industry entitled, "Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials." By ensuring inclusion of underrepresented racial and ethnic minority populations in clinical trials, results can be more generalizable and the safety and efficacy can be accurately assessed within the diverse U.S. population. Limitations exist in the interpretation and implementation of clinical trial results reported using the current racial and ethnic categories, as these standards do not reflect the true diversity of the U.S. population. This is particularly true for the Middle Eastern and North African (MENA) population, which is usually overlooked given the lack of an established category. Although the international MENA region demonstrates the highest prevalence of diabetes in the world at 12.2%, the actual prevalence among MENA individuals living in the U.S. may be "hidden" within the White category. Therefore, data on the MENA population should be disaggregated from data within the White category to not only unmask health disparities, but also to ensure adequate representation in clinical trials. This paper discusses the importance of appropriate representation and inclusion of the MENA population in diabetes clinical trials, which is a critical public health issue domestically and globally.
临床试验中多样化代表性的需求最近得到了美国食品和药物管理局（FDA）题为“多样性计划，以提高代表性不足的种族和族裔人群在临床试验中的参与度”的行业指南的强化。通过确保代表性不足的少数族裔和少数民族人群参与临床试验，可以使结果更具普遍性，并能在美国多样化的人群中准确评估安全性和疗效。目前使用的种族和族裔类别在解释和实施临床试验结果方面存在局限性，因为这些标准不能反映美国人口的真实多样性。中东和北非（MENA）人群尤其如此，由于缺乏既定类别，他们通常被忽视。尽管国际 MENA 地区的糖尿病患病率最高，达到 12.2%，但居住在美国的 MENA 个人的实际患病率可能“隐藏”在白人类别中。因此，应将 MENA 人群的数据与白人类别中的数据分开，不仅要揭示健康差距，还要确保在临床试验中有足够的代表性。本文讨论了在糖尿病临床试验中适当代表和纳入 MENA 人群的重要性，这是一个在国内外都具有重要公共卫生意义的问题。
