The fair inclusion score was created by Bioethics International in collaboration with researchers from Yale and Stanford University, and it becomes the first benchmark for clinical trial equality, diversity, and inclusivity.
The score is informed by transparency and inclusivity data collected from 64 clinical trials of novel drugs and biologics approved by the US Food and Drug Administration (FDA) for oncologic conditions between 2012 and 2017.
Taken into consideration are the transparency of reporting and the representation of three demographic groups that are often underrepresented in clinical trials: sex (percentage of participants that were female), age (percentage of adults older than 64) and race/ethnicity (percentage of participants identifying as Black, Asian and/or Latinx).
All of these factors are then combined to create an inclusion score, which was applied to 25 different companies.
The results of these ranking were published in an article in BMJ Medicine, which found that the reporting of diversity data varied dramatically across the different criteria. Sex was reported by all 25 sponsors, while only 40% reported age, and 24% reported race and ethnicity.
Once the available data was examined, the scale of work left to be done on diversity was revealed: only 56% of sponsors had adequate representation of women in trials, 24% adequately represented older adults, and 16% adequately represented racially and ethnically minoritized patients.
Across the 25 companies examined in the study, the overall fair inclusion score was 81%. However, the median company score for inclusion of racially and ethnically minoritized patients was 68%. United Therapeutics was the only company scoring 100%.
The study acknowledged that there were limitations of its research, highlighting that its focus on oncology therapeutics in the US might not generalize to other products or countries. The authors also highlighted that the product sample size per sponsor is small and therefore could be highly influenced by a single product.
Jennifer Miller, founder of Bioethics International, an associate professor in Yale School of Medicine, and senior author of the study, said, “The purpose of the fair inclusion score is to provide companies and industry partners with a metric to assess how well companies are doing improving clinical trial diversity. Some companies are doing well, and we want to highlight that and learn from them, while pushing the industry to do better.”
The industry has been making efforts in recent years to address the lack of diversity in clinical trials. More funding is going into the space, as companies offering solutions receive more backing, and pharma companies themselves are upping spending.
