Oncology Trials Need to Make More Progress on Diversity, Study Finds
A cross-sectional study of 25 novel oncology drug/biologic sponsors has found “substantial room for improvement” on trial diversity for many of the sponsors, many of which represent the highest ranks of industry.
Researchers from Yale, Stanford and Bioethics International assessed sponsors of novel oncology therapeutics approved by the FDA between 2012 and 2017 to help develop a metric for measuring the fair inclusion of women, older adults (age 65 and up) and racial/ethnic minority groups in pivotal trials.
The study, published in BMJ, evaluated sponsors, their trials and their products on diversity efforts using three measures: transparency (public reporting of participant age, sex and racial/ethnic identity), representation (whether trial participant demographics represented more than 80 percent of the U.S. patient population for the condition) and fair inclusion (the average transparency and representation scores overall and for each demographic group).
Just one sponsor — United Therapeutics — earned perfect fair inclusion marks across the board.
Seven sponsors received top-tier “gold” ratings for scoring in the top quarter of the group: Puma Biotechnology, Sanofi and Takeda (all 89 percent); Amgen and Bristol Myers Squibb (both 88 percent); and Eli Lilly and Merck KGaA (both 87 percent).
Five — Otsuka, Pfizer, Johnson and Johnson, Gilead and Eisai — received “silver” ratings for scoring above the median company score but below the top quarter. The remainder, which scored beneath the median company score, were considered “unrated.”
Drilling down into the study findings, several diversity gaps became apparent. Of the 25 companies, all reported on participant gender, but only 14 (56 percent) were found to adequately represent women in their pivotal trials, while 13 (52 percent) were found to fairly include women.
Just six companies (24 percent) transparently reported ethnic/racial minority identity data, four (16 percent) adequately represented minority groups, and just one sponsor (4 percent) was found to fairly include these patients in their pivotal oncology trials.
Specifically, none of the companies adequately represented Latinx patients, while only four (16 percent) of the companies adequately represented Black patients. Asian patients were better represented but their numbers were still low, being adequately represented by 12 (48 percent) of the companies, according to the analysis.
Inclusion of older adult patients was also found seriously wanting. Ten (40 percent) of the sponsors transparently reported participant age, six (24 percent) adequately represented older adults and five (20 percent) fairly included this population in their pivotal trials, the researchers found.
“Although a few sponsors have done well, most have substantial room for improvement with regards to their inclusion of older adults and racially and ethnically minoritized patients and, to a lesser extent women, in cancer pivotal trials,” the researchers concluded.
Read the full study findings here: https://bit.ly/3QiROtB.