Study shows there is still a long way to go on trial diversity

It's no revelation that the pharma industry has often fallen short when it comes to making sure its clinical trial populations include representation of racial and ethnic minorities, but a new study aims to provide the metrics to do better.

Bioethics International has developed a benchmarking tool for "fair inclusion" in clinical trials, drawing on pivotal trials submitted to the FDA in support of 59 new cancer therapeutics – submitted by 25 sponsors – that were approved by the regulator between 2012 and 2017.

The aim is to identify those companies that are performing well on making sure trials include women, older adults, and racial and ethnic minorities, which is necessary to make sure that the outcomes of studies reflect the safety and efficacy that will be seen when therapies are used in the real world.

Bioethics developed quality measures for fair inclusion and diversity in clinical research, based on transparency and representation, which when applied to the data set found a handful of sponsors performing well, with the majority having "substantial room for improvement."

On the plus side, all 25 sponsors recorded demographic data on sex, age, race, and ethnicity. Women were adequately represented in more than half of the studies (56%), but less than a quarter (24%) hit the mark on older adults, and just 16% for minority groups.

Looking at the data in another way, 80% of products' pivotal trials fairly included women, 24% older adults, and 5% racial and ethnic minorities.

One of the 25 ranked companies – United Therapeutics – achieved a maximum fair inclusion score of 100, while seven companies – Puma Biotechnology, Sanofi, Takeda Pharmaceutical Company, Amgen, Bristol-Myers Squibb, Eli Lilly, and Merck KGaA – scored in the top quartile, earning a 'gold' score.

All the sponsor companies scored more than 50 on the scale, with Spectrum Pharma, Bayer, and Exelixis scoring lowest at 60 or less.

Bioethics is keen to emphasise that the aim of the metric is to highlight those companies that are doing well on transparency and representation so that others can learn from them, according to the organisation's founder, Jennifer Miller.

"Clinical trials supporting FDA approval of new medicines are often tested on patients who are younger, healthier, and more likely to identify as white and male than the patients who use new therapies," she said.

"Despite decades-long policy efforts to improve the inclusion of women, older adults, and racial and ethnic minorities, disparities persist," she added, noting that the use of fair inclusion scores is intended to "drive positive changes to industry practices."

The work on the new metric is published in the journal BMJ Medicine.