ArticleContemporary clinical trials communications2026
Diversity in clinical Trials: The example of systemic lupus erythematosus.
Article in Contemporary clinical trials communications, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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4 authors.
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Abstract
Objective: The FDA requires clinical trials to reflect real-world diversity. Systemic lupus erythematosus (SLE) is a disease that disproportionately affects individuals of Black African descent that has not been assessed for diversity in clinical trials to date. This study compared demographics from two real-world data (RWD) sources and proposes parameters for representative trial populations. Methods: Demographics of United States (US) SLE patients were extracted from electronic health records (EHR) and registry data. These were used to model statistically representative hypothetical trial cohorts and compared with completed SLE trials using statistical tests. Results: Compared with both EHR and registry-derived populations, male participants were significantly underrepresented in US SLE trials (median z-score -1.04 and -0.82; Conclusion: This study demonstrates demographic disparities in SLE trials and offers actionable benchmarks for diversity planning per FDA guidance.
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