It’s no secret that diversity in clinical trials doesn’t exactly mirror that of the U.S. population—Black people make up about 13% of the country’s population, but they comprise less than 3% of participants in oncology or cardiovascular disease studies, an FDA report found in 2017. This disparity can lead to all kinds of problems, such as drugs that don’t work as expected or, worse, do more harm than good.
Bristol Myers Squibb was already working on a plan to boost diversity in clinical trials, but the events of 2020—namely a pandemic that disproportionately affects minorities and a social justice movement reignited by the murder of George Floyd—ramped up its efforts.
“One thing we have always done is to strive for that level of diversity from a clinical trial perspective and certainly look for opportunities where we can do more. When we saw the COVID-19 pandemic impacting society, things started to evolve from there,” said Samit Hirawat, M.D., chief medical officer at Bristol Myers Squibb.
“We saw health outcomes for patients from underrepresented communities and social economic strata differ compared with everybody else,” Hirawat said. “And as racial tensions began to rise, we accelerated our thinking around the need to do more and impact society in a larger way.”
In August, the company unveiled a $300 million commitment to boost its diversity and inclusion efforts. The plan includes company goals, such as reaching gender parity at the executive level and doubling the number of Black and Hispanic and Latino employees by 2022. It also involves building trial sites in underserved communities both urban and rural and training 250 racially and ethnically diverse investigators.
“It’s not just the BMS struggle, but the struggle of society and everyone in the pharma world to really change that and go in a broader way to impact all levels of clinical trials,” Hirawat said.
“We need to be able to do clinical trials in places where the underrepresented communities live, have a dialogue with that community and provide education,” he added.
Having diverse investigators is important in more ways than one.
“We find clinical trial sites where there are diverse investigators have a better rapport and trust with the community—believe it or not, you like and trust the people who talk like you and look like you,” Hirawat said.
Then there’s diversity in how investigators of different racial or ethnic backgrounds may approach a problem for a given patient or study.
“Diversity allows us a differentiation in terms of differentiation in terms of through process, of how these investigators and scientists think differently and solve the problem,” Hirawat said. “Having a diverse set of investigators brings novelty of thought that can apply in the design of a trial, the execution of a trial and the analysis of data we collect from the trial.”