Biopharma companies like Sanofi, United Therapeutics and Bristol Myers Squibb are doing a fair job at including women in clinical trials for oncology drugs, but far more work needs to be done to adequately represent Black and Latinx patients.
That’s the takeaway of a study published Jan. 5 in BMJ Medicine, where the nonprofit Bioethics International outlined the logic behind its new Fair Inclusion score. The score is the first official benchmark of clinical trial diversity and transparency, according to the nonprofit, and considers how many trial participants were women, older adults and part of minority racial and ethnic groups as well as how clearly those numbers were reported.
Bioethics International—which is also behind the Good Pharma Scorecard—applied its new measurement to rank 25 biopharma firms based on pivotal novel oncology drug trials they conducted between 2012 and 2017.
Jennifer Miller, Ph.D., the nonprofit’s founder and an associate professor at Yale School of Medicine, in a press release called the lack of diversity in clinical research a “social justice and public health problem.”
“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,” she said in the release. “Some companies are doing well, and we want to highlight that and learn from them, while pushing the industry to do better.”
United Therapeutics was the only firm to receive a perfect Fair Inclusion Score of 100. Puma, Sanofi, Takeda, Amgen, Bristol Myers Squibb, Eli Lilly and Merck KGaA were awarded “Gold” ratings, with a median score of about 88. Otsuka, Pfizer, Johnson & Johnson, Gilead and Eisai received “Silver” ratings; their median score was 82. Novartis received an 80, while most other firms—including Merck & Co., AstraZeneca, Teva, GSK and Roche—hovered in the 70s.
Exelixis and Bayer both received 60s, while Spectrum’s score was 50.
Fair Inclusion scores were based on the performance of a company, its products and those products' clinical trials. The scores considered how well a trial population mirrored the real-life patient population that would be most likely to use that product based on cancer prevalence rates among different demographics and whether demographic information for the trial was publicly available.
Fair Inclusion scores were boosted by companies' transparency around reporting gender, for which all of them received perfect marks. However, two-thirds of them failed to report age, and a full 75% didn’t report race and ethnicity in at least one trial.
Only 10% of all 62 trials analyzed for inclusion of racial and ethnic groups met the benchmark for adequate representation, with particularly poor inclusion of Black and Latinx individuals. Merely 15% of clinical trials adequately represented Black patients, and only 20% adequately represented Latinx patients. Inclusion of Asian patients lagged too, with a little over two-thirds of trials representing them at an acceptable rate.
To measure transparency, the researchers assessed whether the ethnicity, race, age and sex of participants was publicly stated on ClinicalTrials.gov or in publications that reference the trial.
Bioethics International focused on oncology drug trials because cancer is a leading cause of death in the U.S., Miller told Fierce Biotech in an email. Like most trials, those for oncology drugs have historically looked whiter, younger and more male than the patient population who will ultimately need the treatment.
The nonprofit wants to apply its Fair Inclusion score to trials, products and companies beyond oncology but may have a difficult time due to blind spots in the data.
“It isn’t generally possible to benchmark the adequacy of clinical trial diversity for most other conditions using public data sources,” Miller said. “There are significant gaps in data when it comes to characterizing the incidence and prevalence of diseases and conditions across demographic populations outside of cancer.”
While Bioethics International still aims to report on other clinical trials despite this hurdle, they need funding or a partner to support the work, she said. In the meantime, the nonprofit is working on an interactive tool for its website that will give people a way to parse the results of the scorecard themselves.
Editor's Note: An earlier version of this article described Dr. Miller as an "assistant" professor at Yale. She is an associate professor.