Medically reviewed by Dr. Kimberly Langdon Cull, M.D. on Oct. 4, 2023
A recent international workshop provides actionable recommendations for increasing diversity and inclusion in clinical trials for multiple sclerosis. These guidelines aim to close the gap between trial participants and the broader multiple sclerosis patient population, thereby improving the generalizability of research findings.
- Clinical trials often underrepresent marginalized populations, affecting the generalizability of results.
- Improved reporting standards on social determinants of health and demographic factors are emphasized.
- Diversity plans, community engagement, and cultural competency training are among the recommendations.
Multiple sclerosis (MS) affects a wide range of people across various demographic groups and social determinants of health (SDoH). However, participants in clinical trials for MS treatments often do not reflect the diversity of the patient population. An international workshop was held to address these concerns and develop recommendations to improve diversity and inclusion in MS clinical trials. The workshop results and recommendations are published in the Multiple Sclerosis Journal.
Challenges in Achieving Equitable Trial Participation
A variety of barriers impede the participation of diverse populations in clinical trials. These range from systemic issues like limited availability of trials in tertiary care centers to individual factors like language barriers and implicit bias among providers. Addressing these challenges is key to making trials more inclusive and equitable.
Key Recommendations to Foster Inclusivity
The workshop included a multidisciplinary group of experts and resulted in several recommendations to improve trial diversity. These include the creation of diversity plans, increased community engagement and education, cultural competency training for investigators and study staff, and adaptive trial designs. Investigators are also encouraged to report the demographic and SDoH characteristics of study participants to better understand the reach and impact of the trials.
Implications for Transparency and Reporting Standards
The study also calls for greater transparency in the reporting of population characteristics of participants enrolled in clinical trials. These improvements include the use of the CONSORT-Equity statement and the PROGRESS-Plus framework to better capture relevant demographic information and SDoH factors. By enhancing the transparency and standardization of trial reporting, researchers can provide more accurate findings.
Future Clinical Directions
For healthcare providers, understanding the limitations of current clinical trial populations can guide more informed treatment decisions for a diverse range of MS patients. The recommendations offer a roadmap for clinicians involved in research to design and execute more inclusive trials. Moreover, they present an opportunity to reconsider how evidence-based practices are developed and applied in diverse patient groups.
Source:
Marrie, R. A., Chataway, J., Bierer, B. E., Finlayson, M., Martinez-Lapiscina, E. H., Panagoulias, J., Sormani, M. P., Williams, M. J., & Amezcua, L. (2023). Enhancing diversity of clinical trial populations in multiple sclerosis. Multiple Sclerosis Journal, 29(9), 1174–1185. https://doi.org/10.1177/13524585231189677
