Clinical trial homogeny: 'pressing need' to create diversity

26-Jul-2016 - Last updated on 27-Jul-2016 at 15:37 GMT

(Image: iStock/Ljupco)

While the industry has made progress in advancing diversity in clinical trials, greater expectations may be forthcoming.

David H. Rosmarin, PhD, ABPP, McLean Hospital at Harvard Medical School, suggests one reason research tends to be homogenous “is that researchers strive to keep things simple in order to control for various factors.”

“The downside of this, of course, is that research findings are then not relevant to broader populations than the ones under study,” he told Outsourcing-Pharma.com. “Given national trends in diversity, this is very significant.”

While Rosmarin’s recently published paper specifically address diversity within clinical psychology – and is just one of many opinions on why research tends to be homogenous – the issue is one which is seen throughout the clinical research industry as a whole.

In an effort to combat the concern, FDA commissioner Robert Califf called 2016 “the year of diversity in clinical trials” earlier this year.

Christine Pierre, President, Society for Clinical Research Sites, told Outsourcing-Pharma.com that it was “no surprise” that Califf made this declaration.

“Examining the representation of individuals participating in clinical trials vs. the demographics of those who actually suffer from the target diseases and will be prescribed the marketed products, it makes sense that we need to ensure their representation in clinical trials,” said Pierre, who added that the FDA declaration is just the first step.

“I anticipate more expectations for research population diversity that matches treatment diversity to be forthcoming,” explained Pierre. “The Society for Clinical Research Sites is engaged in multi-stakeholder collaborations to ensure clinical research sites are prepared for this change.”

As part of the administration’s effort to increase diversity in clinical trials, it launched several new activities, such as the Diverse Women in Clinical Trials initiative.

“There is a pressing need to create larger studies with diverse samples,” added Rosmarin, who said that with new ways to collect large amounts of data in real time, such as Amazon's Mechanical Turk and Google's research division, this should be not only possible, but potentially even more cost effective than laboratory-based settings.

Andrew Powaleny, a PhRMA spokesperson told us, “America’s biopharmaceutical industry has long been committed to increasing participation in clinical trials. Science-based inclusion of participants with diverse ethnic and racial backgrounds in clinical trials can further research and help find better ways to fight diseases that disproportionately impact those populations.”

Rosmarin’s series, which will be released as three articles, investigates the outcomes across racially and culturally diverse groups. His aim is to demonstrate the benefits that “diversity science” offers.

He predicts that unless “we start to embrace the fact that not all human beings are alike, clinical science will become increasingly irrelevant to most of the population."

As for rectifying the situation, Rosmarin said, “NIH needs to provide dedicated funding for diversity science. Plain and simple.”