Recently, the FDA declared 2016 The Year of Diversity in Clinical Trials, putting forth a number of initiatives “to push for greater inclusion, including more minority participation” in clinical trials. This effort echoes the sentiment expressed by many following NIH data released in 2014, depicting a bleak picture for diversity in the industry.
The issue at hand? As just one example: while clinical trials generally involve about 13% of the population only 5% of those are African American. And the trend is equally problematic among other minority groups.
The bottom line: minorities are simply not represented in clinical trials in proportions equal to the population. NPR put the problem in perspective in a 2015: “The blood thinner clopidogrel, or Plavix, doesn’t work in the 75 percent of Pacific Islanders whose bodies don’t produce the enzyme required to activate the drug. For them, taking the medication is like taking a placebo.”
“We have been remiss as an industry in customizing our messaging, outreach and education to the very heterogeneous world we live in.”
Taking a New Look
Gretchen Goller, Senior Director of Therapeutic Expertise and PRA Health Sciences
With such large risks involved, it’s not surprising to see a new approach showing up across the industry. I’m In, a combined initiative between the Minority Quality Forum and PhRMA, the Pharmaceutical Research and Manufacturers of America, seeks to reshape perspectives targeted at minority groups to help increase diversity in clinical trials. The web portal encourages patient advocate groups to step up as champions, making a pledge to “help raise awareness about the benefits of clinical trial participation and the need for greater diversity.” Since launching in 2015, the site has accumulated more than 50 organizations to their cause.
Gretchen Goller, Senior Director of Therapeutic Expertise and PRA Health Sciences, agrees that it’s time for a perspective change, especially regarding the intended audience. “The focus should be on the audience and the customer that comprises that audience. We have been remiss as an industry in customizing our messaging, outreach and education to the very heterogeneous world we live in,” she says.
In 2015, the FDA started their Drug Trial Snapshots, giving a much wider view into the demographic makeup of current drug trials. While the database is comprehensive and visibility is important, Goller says there is still a long way to go, especially from the point of view of potential trials participants: “If you were a specific ethnicity and you were informed that there was not one person (or very few) included in the trial process leading up to that approval, you would not be confident on how well that therapy would treat you specifically.”
"CROs need to devote more time and effort into not only understanding the disparity of ethnic representation but also in building relationships with minority health organizations."
Committing to Change, Measuring the Outcomes
When it comes to measurable success, Goller says it’s about building relationships. “CROs need to devote more time and effort into not only understanding the disparity of ethnic representation but also in building relationships with minority health organizations. In addition, they need to be prepared to present solid recruitment plans and strategies that will address these concerns as a standard part of their new trial proposals.”
Whether or not 2016 will truly be the year of diversity in clinical trials is still up for debate. One thing remains true: CROs need to reimagine their approach, forge deeper relationships with patients and advocacy groups, and commit to the change for real advancement.