Clinical trials are an essential source of information about how medical interventions – especially drugs – work in patients. But they have a significant blind spot: The patients they recruit often do not reflect the diversity of the U.S. population.
That was the subject of a panel discussion Tuesday at the Biotechnology Innovation Organization’s annual conference in Philadelphia, “How to Boost Racial, Ethnic and Gender Diversity in Clinical Research.” Moderated by Syneos Health managing director of behavioral insights Kathleen Starr, the panel included Lazarex Cancer Foundation founder Dana Dornsife; Nicole Richie, principal clinical science business strategy leader for immunology, infectious diseases and ophthalmology at Roche’s Genentech subsidiary; African Americans Against Alzheimer’s Executive Director Stephanie Monroe; and Emerson Clinical Resource Institute CEO Fabian Sandoval.
According to a slide shown during the discussion, minorities represent 38.7 percent of the population of the United States, but their rate of inclusion in clinical trials ranges from 16 percent to as low as 2 percent. Among African-Americans, the participation rate is lower than 5 percent, despite a 14 percent greater risk of dying from cancers. Meanwhile, Latinos make up nearly 18 percent of the population, yet they comprise only 1 percent of clinical trial participants.
In the context of clinical research, diversity can have real implications for how much clinicians know about about how drugs work. A 2015 study by researchers at the Food and Drug Administration found that about 20 percent of drugs approved since 2009 have known differences in exposure and response across racial and ethnic groups. Indeed, even the validity of biomarkers can differ across ethnic groups and carriers of genetic disorders.
The barriers are numerous, but often economic in nature. For example, a tank of gas to get to a trial site and parking that costs $40 a day can be a deal breaker, Dornsife said. “I can either take my chances in clinical trial that may or may not work or put food on table – most parents choose food,” she said.
Dornsife and Monroe also pointed to historical barriers that create mistrust and discourage participation, such a history of abuses in the area of medical experimentation. “There’s lot of perception and misperception about whether we have a commitment to treat all equally,” Monroe said.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
According to an FDA statement last year encouraging more participation and diversity in trials, certain populations can be more susceptible to certain diseases like diabetes and heart disease. Moreover, experience has shown that different populations respond differently to drugs. As such, according to the agency, it is important that trials include the kinds of patients more likely to be treated with a drug.
Building trust by demonstrating cultural competency is key to improving diversity in trials, panelists said. One way to do this is to ensure that clinical trial investigators come from diverse backgrounds. “Do you have that cultural understanding of what I eat, why I dress the way I do, why I use the words I say?” Sandoval asked as an example of why such understanding is important.
Richie also pointed to the importance of gender diversity, noting that some drugs – such as immune checkpoint inhibitors in cancers – can show greater efficacy in men than in women. While there is improving balance between male and female subpopulations in trials, it’s “still not quite to par,” she said.
Photo: FotografiaBasica, Getty Images
