11030 Background: Adequate representation of demographic subgroups in clinical trials is essential for understanding the safety and efficacy of novel therapies. We previously developed and piloted the “fair inclusion” measure, which assesses (1) transparency in participant demographics and (2) demographic representation. These metrics were incorporated into the Good Pharma Scorecard, a system evaluating pharmaceutical company performance in bioethics and social responsibility, with sponsors ranked by fair inclusion scores. However, it remains unclear whether sponsors have improved fair inclusion of women, older adults, and racial and ethnic minorities in pivotal trials since the most recent Scorecard. Methods: For transparency, we assessed 6 measures whether the number of (1) women, (2) older adults, (4) Black, (5) Asian, and (6) Latinx participants were publicly reported, and for representation, 5 measures whether the proportion of enrolled (1) women, (2) older adults, (3) Black, (4) Asian, and (5) Latinx represents >80% of the US population with the studied condition. Fair inclusion scores averaged transparency and representation, overall and by subgroup. Results were reported at the trial, product, and sponsor levels and compared across 2012–2017 vs 2018–2023 approvals. Data sources included Drugs@FDA, ClinicalTrials.gov, publications, US Cancer Statistics, and the American Cancer Society. Results: Between January 1, 2018 and December 31, 2023, the FDA approved 75 oncology therapeutics based on 80 pivotal trials from 52 sponsors. At the sponsor level, transparency improved for older adults (2012–2017: 78%, 2018–2023: 95%, p = 0.002) and racial and ethnic minorities (67% vs 91%, p = 0.003). Representation did not improve for women (94% vs 94%, p = 0.99), older adults (85% vs 81%, p = 0.29), or racial and ethnic minorities (75% vs 67%, p = 0.13). Fair inclusion scores improved modestly (81% vs 86%; p = 0.04). Conclusions: Sponsors have improved demographic reporting, particularly for older adults and racial and ethnic minorities. However, representation has not improved for any subgroup. Overall gains in fair inclusion were driven by transparency. Comparison of mean sponsor scores on transparency, representation, and fair inclusion for 2012-2017 vs 2018-2023 oncology FDA approvals, by sex, age, race and ethnicity. 2012-2017 Scores (n = 25) 2018-2023 Scores (n = 52) p-value Women Transparency 96% 99% 0.32 Representation 94% 94% 0.99 Fair Inclusion 97% 95% 0.28 Older Adults Transparency 78% 95% < 0.01 Representation 85% 81% 0.29 Fair Inclusion 79% 86% 0.07 Race and Ethnicity Transparency 67% 91% < 0.01 Representation 75% 67% 0.13 Fair Inclusion 66% 78% 0.06 Overall Transparency 82% 95% < 0.001 Representation <jats:td colspan="1" row
Varma et al. (Wed,) studied this question.