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Demographic Diversity of Clinical Trials for Therapeutic Drug Products: A Systematic Review of Recently Published Articles, 2017-2022.
Chege, Wambui; Poddar, Atasi; Samson, Marsha E; Almeida, Cecilia; Miller, Rihana; Raafat, Dina; Fakhouri, Tala; Fienkeng, Mathilda; Omokaro, Stephanie O; Crentsil, Victor.
Afiliación
  • Chege W; Division of Medical Product Development, Office of Medical Policy Initiatives, Office of Medical Policy, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA.
  • Poddar A; Division of Medical Product Development, Office of Medical Policy Initiatives, Office of Medical Policy, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA.
  • Samson ME; Office of Medical Policy Initiatives, Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
  • Almeida C; Division of Medical Product Development, Office of Medical Policy Initiatives, Office of Medical Policy, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA.
  • Miller R; Division of Medical Product Development, Office of Medical Policy Initiatives, Office of Medical Policy, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA.
  • Raafat D; Division of Medical Product Development, Office of Medical Policy Initiatives, Office of Medical Policy, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA.
  • Fakhouri T; Office of Medical Policy Initiatives, Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
  • Fienkeng M; Division of Medical Product Development, Office of Medical Policy Initiatives, Office of Medical Policy, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA.
  • Omokaro SO; Division of Medical Product Development, Office of Medical Policy Initiatives, Office of Medical Policy, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA.
  • Crentsil V; Office of Medical Policy Initiatives, Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
J Clin Pharmacol ; 64(5): 514-528, 2024 May.
Article en En | MEDLINE | ID: mdl-38098162
ABSTRACT
The US Food and Drug Administration (FDA) encourages the use of enrollment practices that will lead to clinical trials that reflect the population most likely to use the therapeutic product (drug or biologic), if approved. In doing so, the benefit-risk profile of the product may be assessed more completely and offer patients and their health care providers a better understanding of the drug profile and greater confidence in clinical trial results. The objective of this systematic review was to assess recent literature on the demographic diversity of clinical trial participants, describe the methods used in defining clinical trial diversity, and address knowledge gaps to enhance clinical trial diversity. Our literature search initially yielded 246 articles. After applying our eligibility criteria, we conducted a full-text review and analyzed the contents of the 28 remaining articles in our systematic review. Eleven (39%) of the 28 articles used a reference standard to compare the participation of populations in clinical trials to assess diversity. The majority of the 28 articles reported on adult participants; only 5 included pediatric populations. Most articles found that women and minority populations were underrepresented in clinical trials. Some articles proposed solutions to improve clinical trial diversity; however, several did not comment on clinical trial diversity. Despite a growing emphasis on demographic diversity in research, certain populations continue to be underrepresented in clinical trials. There is a need to standardize the definition of diversity in clinical trials. Future research into effective enrollment approaches and appropriate reference standards could improve demographic diversity.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Ensayos Clínicos como Asunto Tipo de estudio: Systematic_reviews Límite: Female / Humans / Male País/Región como asunto: America do norte Idioma: En Revista: J Clin Pharmacol Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Ensayos Clínicos como Asunto Tipo de estudio: Systematic_reviews Límite: Female / Humans / Male País/Región como asunto: America do norte Idioma: En Revista: J Clin Pharmacol Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos