A lack of diversity among participants in clinical studies is a persistent problem in medicine. Researchers at Boston Medical Center (BMC) report that one way to address this deficit is to increase the diversity of the clinical research staff who directly work with patients enrolled in studies.1
Study details. For their retrospective study, the BMC researchers examined screening log information collected on 1,380 eye clinic patients from an urban, academic hospital who were approached to participate in any of 10 prospective ophthalmic clinical studies between January 2015 and December 2021. The screening logs included information such as each patient’s decision to participate or decline, basic demographic information, and the research staff member who approached the patient. The average patient age was 58 years old—43.5% were Black, 25.1% were Latino or Hispanic, 28.6% were White, and 2.8% identified as being part of another race or ethnicity. Another 5.8% declined to provide demographic information.
STUDY RECRUITMENT. If a research staff member is of the same race or ethnicity as the patient, patient participation in the study is more likely, new research suggests.
Results. The investigators discovered that if a research staff member was of the same race or ethnicity as the patient, 65.1% of patients consented to study participation compared to 39.9% who consented when approached by a staff person of a different race or ethnicity.
Black, Hispanic, and Latino patients were less likely to consent to participate in studies compared to White peers. Those who were of a lower socioeconomic status were also less likely to be part of clinical studies. When clinical staff were of an ethnic or racial identity similar to prospective participants, the odds of participant consent increased by a factor of nearly 3.
Unexpected finding. Lead author Manju L. Subramanian, MD, FACS, at BMC and Boston University Chobanian & Avedisian School of Medicine, said she was struck by the fact that communicating with patients in their primary language was not associated with higher odds of consent in a clinical study. But, she said, “It’s possible that our inability to detect this association was due to having a smaller sample size of languages other than English.”
Pursuing health equity. Previous research shows that there are racial and ethnic differences in the prevalence of some diseases and that specific patient groups respond differently to the same treatments, Dr. Subramanian said.
“Achieving health equity means that treatments need to work equally well for all patients, therefore clinical trials need to enroll patient cohorts that match the demographics of the disease burden,” Dr. Subramanian said, noting that racial and ethnic minorities participate in clinical studies at significantly lower rates across all medical specialties.
There is a need to develop novel strategies to increase enrollment of racial and ethnic minorities into clinical studies, she said. “Our study shows that the odds of affirmative consent are increased when there is racial concordance between research staff and the patient being approached to participate in a clinical study,” she said, but it will require a concerted effort from the medical community at large and especially from investigators and study sponsors.
“I think the medical research community can consider this one strategy to improve participant enrollment, but I don’t believe this is the only strategy. Other interventions may include reducing the burden of time and travel cost, community outreach, and promoting community support.”
1 Bains A et al. JAMA Ophthalmol. 2023;141(11): 1037-1044.
Relevant financial disclosures: Dr. Subramanian—None.
For full disclosures and the disclosure key, see below.
Full Financial Disclosures
Dr. Subramanian None.
Dr. Wladis FuzeHub: S; Lions Eye Foundation: S; Horizon Therapeutics: C,L; Praxis Biotechnology: P.
Dr. Anderson NHS: E; NIHR (UK): S; Wellcome: S.
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