Achieving diversity in clinical trial enrollment by reducing burden and increasing value: A patient-centered approach

Abstract

Growing attention has been placed on the importance of racial and ethnic diversity in clinical trials. Non-White individuals accounted for less than 25% of all clinical trial participation in the United States from 2015 to 2019, and only 13% of participants endorsed a Hispanic or Latino identification [ [1] U.S. Food and Drug Administration. 2015–2019 Five-Year Summary and Analysis of Clinical Trial Participation and Demographics Drug Trials Snapshots. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshotsDate: 2020 Google Scholar , [2] Lolic M. Araojo R. Okeke M. Woodcock J. Racial and ethnic representation in US clinical trials of new drugs and biologics, 2015-2019. JAMA. 2021; 326: 2201-2203 Crossref Scopus (7) Google Scholar ]. In gynecologic oncology, racial and ethnic minority participation in clinical trials, though improved over time, still falls short of mirroring the diversity of the population [ [3] Scalici J. Finan M.A. Black J. Harmon M.D. Nicolson W. Lankes H.A. et al. Minority participation in gynecologic oncology group (GOG) studies. Gynecol. Oncol. 2015; 138: 441-444 Abstract Full Text Full Text PDF PubMed Scopus (43) Google Scholar ]. Without representative trial enrollment, we will never have accurate, generalizable, and meaningful information to provide our patients regarding treatment options, benefits, and risks. Documented unethical past medical experimentation on enslaved Black people, the Tuskegee Syphilis Study, and decades of historic barriers and obstacles to equitable health services rooted in systemic racism have played a role in mistrust and worse healthcare outcomes among the Black community [ [4] Akinade T. Kheyfets A. Piverger N. Layne T.M. Howell E.A. Janevic T. The influence of racial-ethnic discrimination on women's health care outcomes: a mixed methods systematic review. Soc. Sci. Med. 2023; 316114983 Crossref Scopus (6) Google Scholar , [5] Harris Y. Gorelick P.B. Samuels P. Bempong I. Why African Americans may not be participating in clinical trials. J. Natl. Med. Assoc. 1996; 88: 630-634 PubMed Google Scholar ]. Other factors like economic and logistical barriers, lack of recommendation by providers, and clinical trial literacy are additional drivers of poor enrollment [ 6 George S. Duran N. Norris K. A systematic review of barriers and facilitators to minority research participation among African Americans, Latinos, Asian Americans, and Pacific islanders. Am. J. Public Health. 2014; 104: e16-e31 Crossref PubMed Scopus (807) Google Scholar , 7 Rodriguez-Torres E. Gonzalez-Perez M.M. Diaz-Perez C. Barriers and facilitators to the participation of subjects in clinical trials: an overview of reviews. Contemp. Clin. Trials Commun. 2021; 23100829 Crossref Scopus (13) Google Scholar , 8 Unger J.M. Hershman D.L. Till C. Minasian L.M. Osarogiagbon R.U. Fleury M.E. et al. "when offered to participate": a systematic review and meta-analysis of patient agreement to participate in cancer clinical trials. J. Natl. Cancer Inst. 2021; 113: 244-257 Crossref PubMed Scopus (66) Google Scholar ]. Multiple groups, including the U.S. Food and Drug Administration and the American Society of Clinical Oncology, have created calls, guidelines, and action plans for increasing participation from diverse populations in cancer trials [ [9] Oyer R.A. Hurley P. Boehmer L. Bruinooge S.S. Levit K. Barrett N. et al. Increasing racial and ethnic diversity in cancer clinical trials: an American Society of Clinical Oncology and Association of Community Cancer Centers Joint Research Statement. J. Clin. Oncol. 2022; 40: 2163-2171 Crossref PubMed Scopus (19) Google Scholar , [10] U.S. Food and Drug Administration. Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials Draft Guidance for Industry. https://www.fda.gov/regulatory-informationDate: 2022 Google Scholar ].