Does Ethnicity Influence Recruitment into Clinical Trials of Parkinson’s Disease?

Abstract

Background: Lack of participation of black and minority ethnic communities (BAME) in registered clinical trials is a concern as data emerging from these studies are used to licence new drugs or other interventions, even though findings made in such selected study populations have limited external validity in the aforesaid ethnic groups. Objective: We used Parkinson’s disease (PD), the fastest rising neurodegenerative disorder in the world, as an exemplar condition to test our hypothesis that participants from BAME communities are underrepresented in clinical trials. Methods: A systematic search of clinical trials registered on a Clinicaltrials.gov database which queried for PD with racial distribution data from 2017 to 2021. Results: Out of 266 trials considered, 54 trials were published in peer reviewed journals. Among these, only 23 (42.65%) publications reported data regarding the racial distribution of the participants. Out of these, five studies involved mixed racial participation and two trials included black subjects. Conclusion: We found that inclusion of under-represented BAME groups in recently published clinical trials is low, at only 21.57%, and is not even considered in most studies. Out of the reviewed trials, only 5 (21.75%) studies reported detailed demographic categories with black minorities enrolment. This constitutes a severe under-representation when compared to the proportion of Black or African American in the UK population (3%). Results of this study identified the need for better reporting of racial composition in clinical trials. We strongly recommend that future studies should consider ethnicity and other issues around diversity when designing and implementing the clinical trials, not only in the PD field but also beyond.

Addressing the gap for racially diverse research involvement: the King’s Model for Minority Ethnic Research Participant Recruitment

“…The data was a board re ection in line with the recent studies published from our group in trials related to Parkinson's disease (PD) as an exemplar. A detailed survey of clinical trials in PD from 2017 to 2021 showed a shocking lack of recruitment of EM subjects to clinical trials[9]. In another study from our group, a concerning signi cant lack of analgesia was reported in black PD subjects with pain compared to white Caucasian PD subjects with pain[19].…”

“…Despite this work and a wide literature existing concerning the need for the inclusion of ethnic minorities (EM) in research [8], a recent report demonstrates that little effort has been made to promote diversity in research and in real terms, where diverse populations are available, research recruitment remains largely limited to white Caucasian, middle class, educated individuals [9]. In addition, a pre-pandemic systematic review investigating researcher reported strategies for non-white recruitment into clinical trials in the United Kingdom highlighted that limited strategies have been employed to increase recruitment among ethnic minorities [10].…”

Can Continuous Levodopa Delivery Be Achieved in the Absence of Intrajejunal Levodopa Infusion? Implications for India and Underserved Countries

“…Another aspect to consider while addressing inequalities of care in the context of CDD is that even the most recent long‐acting levodopa‐based treatments, such as IPX‐203 (a new extended release levodopa/carbidopa), 27 subcutaneous levodopa/carbidopa or foslevodopa/foscarbidopa, 28 as well as the Accordion Pill (delivery based on gastric retention of multilayer films containing immediate‐ and controlled‐release levodopa/carbidopa) 29 among others, have been investigated in clinical trials recruiting almost entirely White patients, with a small number of patients belonging to ethnic minorities 30 . This has been recently highlighted by a study conducted by Lau and colleagues, 30 showing that the inclusion of under‐represented ethnic minorities groups in recently published clinical trials for PD is only 21.57%, and is not even considered in most studies. This constitutes a severe underrepresentation when compared to the proportion, for example, of Black or African American in the UK and United States (US) population 30 .…”

The impact of multiple gender dimensions on health-related quality of life in persons with Parkinson’s disease: an exploratory study

“…The under-representation of different socioeconomic and ethnic groups, as well as women in PD research, result in an incomplete picture of the true impact on individual quality of life. [ 4 – 7 ]…”