Racial, Ethnic and Sex Representation in Tourette's Syndrome Clinical Trials: A Meta-Analysis

Area of Science:

• Clinical trial diversity and health equity research.
• Neurology and neurodevelopmental disorders.
• Evidence-based medicine and treatment disparities.

Background:

• Equitable representation in clinical trials is crucial for effective treatments and reducing health disparities.
• Lack of data exists regarding racial, ethnic, and sex representation in Tourette's Syndrome (TS) treatment trials.

Purpose of the Study:

• To assess the representation of racial, ethnic, and sex subgroups in randomized controlled trials (RCTs) for Tourette's Syndrome medications.
• To identify potential disparities in participant enrollment within TS clinical research.

Main Methods:

• Searched multiple databases (CENTRAL, Embase, PsycINFO, PubMed, Web of Science, ClinicalTrials.gov) for US-based TS RCTs.
• Calculated the participation-to-prevalence ratio (PPR) for racial, ethnic, and sex subgroups.
• Employed random-effects meta-analysis for data pooling and meta-regression to explore temporal trends.

Main Results:

• Forty RCTs with 1717 participants were analyzed; sex data was reported in all, but race (55%) and ethnicity (30%) data were less consistently available.
• Reporting of race and ethnicity data improved over time.
• Significant underrepresentation was found for Asian, Black, Hispanic, and female participants (PPRs < 1.0). Only Hispanic enrollment showed improvement over time.

Conclusions:

• Disparities in racial, ethnic, and sex representation exist in Tourette's Syndrome medication RCTs.
• Under-enrollment of minority groups may stem from diagnosis disparities, recruitment challenges, or both.