Clinical research in the US needs to better reflect the population's changing demographics in order to better understand the factors that lead to disease or health, according to an article written by concerned physicians and scientists representing several universities within the U.S. published in this week's PLOS Medicine.
An individual's disease risk and response to treatment are affected by genetic, social, and environmental factors. Therefore, the authors argue that study populations should mirror the global community to better capture the rich diversity of human biological variability and to conduct better science and optimize clinical therapies.
The authors cite an ongoing paucity of research involving racial and ethnic minorities. This underrepresentation, say the authors, demonstrates that the National Institutes of Health (NIH) Revitalization Act in 1993, which aimed to diversify clinical research study populations by race/ethnicity, has not yet fulfilled its goals. The authors make specific recommendations in their call for improved participation of racial and ethnic minorities in clinical and biomedical research.
The inclusion of women, minorities, and children is a requirement for current NIH grant applications. However, the authors argue that diversity of race/ethnicity among study participants is rarely enforced as a criterion for assigning priority scores for NIH grant applications, and that NIH and grant reviewers should be required and empowered to enforce this criterion as required by the Revitalization Act. The authors also state that the lack of diversity precludes a growing proportion of Americans from fully benefiting from clinical and biomedical advances. Finally they call for increased financial support for NIH to cover the higher costs of reaching these populations, and for empowering the NIH and related agencies to improve diversity in clinical and biomedical research.
The authors say: "Adequate representation of diverse populations in scientific research is imperative as a matter of social justice, economics, and science."
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Essay
Funding:
This study was supported in part by National Institutes of Health R01-HL117004 and HL104608 grants, the RWJF Amos Medical Faculty Development Award, the Sandler Foundation and the American Asthma Foundation to EGB, and the National Institute On Minority Health And Health Disparities under Award Number P60 MD006902 and R25MD006832. SSO was in part supported by the Flight Attendant Medical Research Institute. MPY was funded by a Postdoctoral Fellowship from Fundación Ramón Areces. JG was supported in part by NIH Training Grant T32 (GM007546) and career development awards from the National Heart, Lung and Blood Institute (K23HL111636) and NCATS KL2 (KL2TR000143), as well as the Hewett Fellowship. RMG was supported by the National Institutes of Health (U01AI034989, 5K12HD052163, P01 AI083050-02, R01-A122590, R01-A123240) and The J. David Gladstone Institutes (P01 AI083050-02). The content of this publication is solely the responsibility of the authors and does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the US Government. The funders had no role in writing the article, decision to publish, or preparation of the manuscript but did provide feedback on the precision of wording regarding the award rate for non-white applicants for NIH grants and reviewer bias.
Competing Interests:
The authors have read the journal's policy and have the following conflicts: EGB serves as an advisor to the National Academy of Sciences to advise them and the US Congress on gene-environment interactions. EGB also serves on the Expert Panel for President Obama's Precision Medicine Initiative. EGB, SSO, JG, NT, MPY, NEB, MJW, DMdB, KBD, AHBW, LNB, RMG, CG, and NRP are involved in health disparities research funded by NIH.
Citation:
Oh SS, Galanter J, Thakur N, Pino-Yanes M, Barcelo NE, White MJ, et al. (2015) Diversity in Clinical and Biomedical Research: A Promise Yet to Be Fulfilled. PLoS Med 12(12): e1001918. doi:10.1371/journal.pmed.1001918
Author Affiliations:
Department of Medicine, University of California, San Francisco, San Francisco, California, United States of America
Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, San Francisco, California, United States of America
CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain
Research Unit, Hospital Universitario N.S. de Candelaria, Tenerife, Spain
Departments of Clinical Pharmacy, Epidemiology, and Biostatistics, University of California, San Francisco, San Francisco, California, United States of America
Department of Medicine, San Francisco General Hospital, San Francisco, California, United States of America
Department of Laboratory Medicine, University of California, San Francisco, San Francisco, California, United States of America
School of Health Sciences, Human Services and Nursing, Department of Health Sciences, Lehman College, City University of New York, Bronx, New York
Marcus Autism Center, Children's Healthcare of Atlanta, Atlanta, Georgia, United States of America
Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, United States of America
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Contact:
Esteban Gonzalez Burchard, M.D., M.P.H.
esteban.burchard@ucsf.edu
415-514-9677
Departments of Bioengineering & Therapeutic Sciences and Medicine
University of California, San Francisco
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UNITED STATES
Journal
PLoS Medicine