Objective: To perform a systematic review and meta-analysis on recruitment of people with Parkinson’s disease (PwP, PD) from different ethnic and racial groups in disease-modifying randomized clinical trials.

Background: There is a historic underrepresentation of racial and ethnic minoritized people in clinical trials for PD, which substantially limit the generalizability of these studies.

Method: We searched PubMed, Embase, and Cochrane Library for clinical trials for potential disease-modifying therapies for PD including PwP from different ethnic and racial groups. Only multi-center double-blind, randomized, placebo-controlled clinical trials (DBRCT) evaluating pharmacological therapies were evaluated. The primary outcome was race and/ or ethnicity prevalence. Secondary outcomes were other social determinants of health, including gender, educational level, and income. We computed pooled prevalence of minoritized groups, with 95% confidence intervals (CIs). Statistical analysis was performed using R (version 4.3.1).

Results: A total of 6,383 participants from sixteen randomized clinical trials were included. Race and ethnicity were reported in thirteen studies (81.25% of all studies, or 4,965 participants). Among the studies that reported race and ethnicity of participants, the overall percentage of people not identifying as White was 3.69% (183), Hispanic/Latino 0.92% (46), Asian 0.48% (24), Black/African American 0.36% (18), American Indian and more than one race 0.08%, Native Hawaiian 0.02% (1), Unknown/not reported 1.67% (83) and Other 0.18% (9). Gender was reported in all studies (63.9% men, 36.1% women). Educational level was described in three RCTs (18.75% of all studies), and income in only two studies (12.5% of all studies).

Conclusion: There is an underrepresentation of people from minoritized ethnic and racial groups in disease-modifying clinical trials for PD. Other social determinants of health, such as income and educational level are rarely reported in clinical trials, despite their impact on disease risk and progression. Lacking efforts to include more diverse populations in clinical trials represent an obstacle for the applicability of effective disease-modifying therapies in PD.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/recruitment-of-ethnoracially-diverse-participants-for-disease-modifying-drug-trials-in-parkinsons-disease-are-we-doing-it-right-a-systematic-review-and-meta-analysis/