Examining Racial-ethnic minority inclusion rates in Stroke Clinical Trials Manuscripts
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.
Learning Areas:Public health or related laws, regulations, standards, or guidelines
Public health or related public policy
Describe NIH policy for the inclusion of minorities and women in clinical trials. Discuss research limitations of low participation rates among women and race-ethnic in clinical trials in the U.S. Understand the policy implications of NIH mandates related to participation rates of racial/ethnic groups and women
Keyword(s): Federal Policy, Policy/Policy Development
Qualified on the content I am responsible for because: I am a Co-Investigator on a NIH funded project, The National Initiative for Minority Involvement in Neurological Clinical Trials, that aims to develop and test tools, procedures and guidelines to improve racial and ethnic recruitment and retention in clinical trials. I am an Associate Professor at the NYU College of Global Public Health and have expertise in health disparities research.
Any relevant financial relationships? No
I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.