Examining Racial-ethnic minority inclusion rates in Stroke Clinical Trials Manuscripts

Within the past twenty years, U.S. Congress implemented several policies and mandates to improve female and racial-ethnic minority inclusion rates in clinical trials. Despite legislative intervention, published clinical trial manuscripts do not consistently report female and minority demographic information.  Low inclusion rates present a significant challenge, limiting the generalizability of tested therapeutics and contributing to disparities in access and treatment.

The National Initiative for Minority Involvement in Neurological Clinical Trials (NIMICT) undertook a systematic scoping review on Medline and OvidSP platforms to identify stroke clinical trial primary outcomes manuscripts from 1995-2013 to examine female and minority participation rates. Manuscripts were systematically evaluated and screened for inclusion.  Eligible manuscripts were examined for: funding source, enrollment rates, and inclusion of participant demographic information (sex and race-ethnicity).

The review identified 3,887 manuscripts, of which 576 were eligible, reporting on a total of 734,003 participants enrolled across 200 clinical trials. Nearly one third of manuscripts were NIH funded. All of the manuscripts included the participants’ sex, with median female participation at 38.3%. Half (49.0%) included the clinical trial participant racial ethnic information.  Among those manuscripts, the median proportion (IQR) of White/Caucasian participants was 81%. Of that group, two-thirds (64%) included participation of patients from racial-ethnic groups other than White/Caucasian.

Enhanced reporting of trial participant demographic information will provide additional insights to improve disparities in trial participation, but will also provide evidence for clinical policy stakeholders to move the discussion forward on diversifying inclusion in clinical trials and improve reporting structures.