Inclusion of Middle Eastern and North African populations in diabetes clinical research.
J Natl Med Assoc
; 115(4): 454-458, 2023 Aug.
Article
em En
| MEDLINE
| ID: mdl-37414643
ABSTRACT
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.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Etnicidade
/
Diabetes Mellitus
Tipo de estudo:
Guideline
/
Risk_factors_studies
Limite:
Humans
País/Região como assunto:
America do norte
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article