Enhancing diversity of clinical trial populations in multiple sclerosis

Author:

Marrie Ruth Ann1ORCID,Chataway Jeremy2,Bierer Barbara E3,Finlayson Marcia4ORCID,Martinez-Lapiscina Elena H5,Panagoulias Jennifer6,Sormani Maria Pia7ORCID,Williams Mitzi Joi8,Amezcua Lilyana9ORCID

Affiliation:

1. Departments of Internal Medicine and Community Health Sciences, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, MB, Canada

2. Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, UCL Queen Square Institute of Neurology, Faculty of Brain Sciences, University College London, London, UK/National Institute for Health Research, University College London Hospitals, Biomedical Research Centre, London, UK/Medical Research Council Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK

3. The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard, Cambridge, MA, USA/Harvard Medical School, Boston, MA, USA

4. School of Rehabilitation Therapy, Faculty of Health Sciences, Queen’s University, Kingston, ON, Canada

5. Center of Neuroimmunology, Laboratory of Advanced Imaging in Neuroimmunological Diseases, Hospital Clinic Barcelona, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona, Barcelona, Spain/Office of Therapies for Neurological and Psychiatric Disorders, Human Medicines Division, European Medicines Agency, Amsterdam, The Netherlands

6. Foundation for Angelman Syndrome Therapeutics, Austin, TX, USA

7. Department of Health Sciences, University of Genoa, Genoa, Italy

8. Joi Life Wellness Group MS Center, Atlanta, GA, USA

9. Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA

Abstract

Background:Demographic characteristics, social determinants of health (SDoH), health inequities, and health disparities substantially influence the general and disease-specific health outcomes of people with multiple sclerosis (MS). Participants in clinical trials do not represent all people with MS treated in practice.Objective:To provide recommendations for enhancing diversity and inclusion in clinical trials in MS.Methods:We held an international workshop under the Auspices of the International Advisory Committee on Clinical Trials in MS (the “Committee”) to develop recommendations regarding diversity and inclusivity of participants of clinical trials in MS. Workshop attendees included members of the Committee as well as external participants. External participants were selected based on expertise in trials, SDoH, health equity and regulatory science, and diversity with respect to gender, race, ethnicity, and geography.Results:Recommendations include use of diversity plans, community engagement and education, cultural competency training, biologically justified rather than templated eligibility criteria, adaptive designs that allow broadening of eligibility criteria over the course of a trial, and logistical and practical adjustments to reduce study participant burden. Investigators should report demographic and SDoH characteristics of participants.Conclusion:These recommendations provide sponsors and investigators with methods of improving diversity and inclusivity of clinical trial populations in MS.

Publisher

SAGE Publications

Subject

Neurology (clinical),Neurology

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