Improving Racial and Ethnic Equity in Clinical Trials Enrolling Pregnant and Lactating Individuals

Author:

Louis‐Jacques Adetola F.1,Heuberger Anika J.2,Mestre Cathleen T.1,Evans Victoria F.1,Wilson Roneé E.3,Gurka Matthew J.1,Lewis Tamorah R.45

Affiliation:

1. University of Florida College of Medicine Gainesville FL USA

2. University of Florida Gainesville FL USA

3. University of South Florida College of Public Health Tampa FL USA

4. Department of Paediatrics Division of Neonatology The Hospital for Sick Children (SickKids) Toronto ON USA

5. Department of Paediatrics Division of Clinical Pharmacology and Toxicology The Hospital for Sick Children (SickKids) Toronto ON USA

Abstract

AbstractRacial and ethnic marginalized populations have historically been poorly represented, underrecruited, and underprioritized across clinical trials enrolling pregnant and lactating individuals. The objectives of this review are to describe the current state of racial and ethnic representation in clinical trials enrolling pregnant and lactating individuals and to propose evidence‐based tangible solutions to achieving equity in these clinical trials. Despite efforts from federal and local organizations, only marginal progress has been made toward achieving equity in clinical research. This continued limited inclusion and transparency in pregnancy trials exacerbates health disparities, limits the generalizability of research findings, and may heighten the maternal child health crisis in the United States. Racial and ethnic underrepresented communities are willing to participate in research; however, they face unique barriers to access and participation. Multifaceted approaches are required to facilitate the participation of marginalized individuals in clinical trials including partnering with the local community to understand their priorities, needs, and assets; establishing accessible recruitment strategies; creating flexible protocols; supporting participants for their time; and increasing culturally congruent and/or culturally sensitive research staff. This article also highlights exemplars in pregnancy research.

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference82 articles.

1. National Academies of Sciences Engineering and Medicine; Policy and Global Affairs; Committee on Women in Science Engineering and Medicine; Committee on Improving the Representation of Women and Underrepresented Minorities in Clinical Trials and Research.Bibbins‐DomingoK HelmanA eds.Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups.Washington (DC):National Academies Press (US); May 17 2022.

2. Racial and ethnic differences in preterm birth: A complex, multifactorial problem

3. Minority Representation in Clinical Trials in the United States

4. Race, Racism, and Racial Disparities in Adverse Birth Outcomes

5. Racial Disparities in Adverse Pregnancy Outcomes and Psychosocial Stress

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