Affiliations: [a] Institute of Psychiatry, Psychology & Neuroscience at King’s College and King’s College Hospital NHS Foundation Trust, London, UK
| [b] Parkinson Foundation Centre of Excellence, King’s College Hospital, London, UK
| [c] National Institute for Health Research (NIHR) Applied Research Collaboration South London (NIHR ARC South London), King’s College Hospital NHS Foundation Trust, London, UK
| [d] Paediatric Respiratory Medicine, King’s College Hospital, London, UK
| [e] Institute of Liver Studies, King’s College Hospital, NHS Trust Foundation, London, UK
| [f] Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Centre of Expertise for Parkinson & Movement Disorders, Radboud University Medical Centre, Nijmegen, The Netherlands
Correspondence:
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Correspondence to: Kallol Ray Chaudhuri, Department of Basic and Clinical Neuroscience, The Maurice Wohl Clinical Neuroscience Institute, King’s College London, Cutcombe Road, London SE5 9RT, UK. Tel.: +44 203 299 7153; E-mail: [email protected].
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.
