Minority Enrollment in Parkinson’s Disease Clinical Trials: Meta-Analysis and Systematic Review of Studies Evaluating Treatment of Neuropsychiatric Symptoms

Article type: Research Article

Authors: Di Luca, Daniel G.^{; *} | Sambursky, Jacob A. | Margolesky, Jason | Cordeiro, Joacir Graciolli | Diaz, Anthony | Shpiner, Danielle S. | Moore, Henry P. | Singer, Carlos | Luca, Corneliu

Affiliations: Department of Neurology, University of Miami Miller School of Medicine, Miami, FL, USA

Correspondence: [*] Correspondence to: Daniel G. Di Luca, MD, Department of Neurology, University of Miami Miller School of Medicine, 1120 NW 14th & Street, 13th floor, Miami, FL 33136, USA. E-mail: [email protected].

Abstract: Background:Randomized clinical trials (RCTs) in Parkinson’s disease (PD) have historically enrolled a low number of underrepresented minorities, lessening the generalizability of therapeutic developments. Although there are racial disparities in PD, little is known regarding neuropsychiatric symptoms and other nonmotor manifestations across all races/ethnicities. Objective:To assess minority participation in PD trials evaluating the treatment of neuropsychiatric symptoms and explore underlying reasons. Methods:We systematically searched PubMed and Embase for RCTs with a primary goal of treating neuropsychiatric symptoms in PD patients from 2000-2019. The pooled prevalence and 95% confidence interval (CI) of being white and enrolled in a clinical trial was calculated using the inverse variance method. I-square was calculated as a measure of heterogeneity and meta-regression was used to evaluate temporal trends. Results:We included 63 RCTs with a total of 7,973 patients. In pooled analysis, 11 (17.5%) RCTs reported race/ethnicity. Of studies reporting this data, 5 African American (0.2%), 16 Hispanics (0.64%), and 539 Asians (21.44%) were enrolled. The pooled prevalence of being white in clinical trials was 98% (CI 0.97–0.98, p < 0.001), with 1,908 patients (75.8%). NIH-funded studies were most likely to report racial data when compared to non-NIH trials (p = 0.032). Conclusion:This large pooled analysis found a small percentage of RCTs reporting race/ethnicity when evaluating treatment of neuropsychiatric symptoms in PD. There was a disproportionally high number of white patients when compared to African Americans and Hispanics. More studies are needed to investigate this discrepancy and improve rates of & minority enrollment in PD trials.

Keywords: Health care disparities, meta-analysis, neuropsychiatry, Parkinson’s disease, randomized clinical trials

DOI: 10.3233/JPD-202045

Journal: Journal of Parkinson's Disease, vol. 10, no. 4, pp. 1709-1716, 2020