Racial, Ethnic, Sex, and Geographical Diversity in Myositis Clinical Trials

Area of Science:

• Clinical Trials
• Rheumatology
• Health Equity

Background:

• Idiopathic inflammatory myopathies (IIM) are rare autoimmune diseases affecting muscles.
• Randomized clinical trials (RCTs) are crucial for advancing IIM treatment.
• Understanding participant demographics and site distribution in IIM RCTs is vital for generalizability.

Purpose of the Study:

• To assess the reporting and representation of race, ethnicity, sex, and geographic distribution in IIM RCTs.
• To identify trends and disparities in participant enrollment and site selection.
• To evaluate the implications for the generalizability of IIM clinical trial findings.

Main Methods:

• Systematic literature review of IIM RCTs published between 2010-2023.
• Analysis of sex/gender reporting following established guidelines.
• Evaluation of race/ethnicity reporting, participant demographics, and geographic site distribution (including US urban/rural and medically underserved areas).

Main Results:

• Race was appropriately reported in 58% of RCTs; Black, Asian, and Hispanic/Latino participants were underrepresented (3%, 7%, 2%).
• Ethnicity reporting was limited (26%), with 16% conflating race and ethnicity.
• Most trials included over 45% women; sites were concentrated in North America and Europe, with none in South America or Africa. US sites predominantly in metropolitan areas, with limited reach into medically underserved areas.

Conclusions:

• Significant gaps exist in racial, ethnic, and geographic representation within IIM RCTs.
• Inadequate reporting and limited diversity raise concerns about the applicability of trial findings to the broader IIM patient population.
• Addressing these disparities is essential for improving the relevance and impact of IIM research.