A Push To Address Issue Of Diversity In Clinical Trials

By Benjamin Ross

May 5, 2020 | The first female crash test dummy was implemented by the National Highway Traffic Safety Administration (NHTSA) in 2003, and there is still no crash test dummy currently in use that effectively takes into account the biological differences between male and female bodies despite that females make up 50% of the driving population in the U.S., and that a female driver or passenger wearing their seatbelt is 17% more likely to be killed in a crash than a man.

The clinical trial industry faces a similar dilemma.

“While strides have been made in the treatment of heart disease and stroke, women are still underrepresented in research and clinical trials,” Lori Mosca, a Professor of Medicine at Columbia University Medical Center, explains in an email interview with Clinical Research News. “The current state is a serious concern: women make up less than half of clinical trial participants and women of color only account for 3%.”

Data from the U.S. Food and Drug Administration (FDA) shows the disparity on a larger scale: only 4% of clinical trial participants are black, 4% are Hispanic, and 15% are Asian, despite minority groups overall in the U.S. having both the highest death rate and shortest survival rate for most cancers.

Karen Winkfield, Director of the Office of Cancer Health Equity at Wake Forest Baptist Health, tells Clinical Research News it’s tough to look at the numbers and say the medicines being used in these current trials are going to be truly effective in diverse populations.

“The health disparities we see are a huge problem,” Winkfield said. “Many of the early clinical trials that shaped the drugs and medicines we use today exclusively enrolled white men. . . We need to know the entire spectrum of issues that actually contribute to these disparities when it comes to the incidence of cancers and also the outcomes once people are undergoing treatment.”

Winkfield is a Health Equity Committee member of Stand Up To Cancer (SU2C), a coalition that promotes collaborative cancer research programs that recently announced an initiative to increase minority representation in clinical trials. With this initiative, future SU2C-supported research grant proposals will now be required to include and address issues related to recruitment and retention of patients from ethnic groups to improve diverse participation in cancer clinical trials.

But does race really matter when it comes to the types of drugs we make? While our genetic makeup is similar, Winkfield says there may be differences in how a gene is expressed between different ethnic populations, meaning certain diseases affect one race more than another race. For instance, the CDC reports that 1 out of every 365 African Americans are born with sickle cell disease (SCD).

Mosca says heart disease is another area where disparities exist, primarily between men and women. As a member of the American Heart Association’s “Go Red for Women” initiative, Mosca is committed to empowering women to contribute to health research.

“Heart disease has long been thought of as a man’s disease,” Mosca said. “The reality is cardiovascular disease is the leading cause of death among women. We now know that women often don’t have the same cardiac event symptoms as men do, and women may not respond to medications the same way men do.”

“That’s why enrollment in clinical trials for diverse populations is so important,” said Winkfield. “It allows you to say, ‘We know that this medicine is going to be effective in every single population.’”

These fundamental differences are evident not only for symptom recognition, but also treatment times and lifesaving support measures, says Mosca.

“Women having heart attacks wait more than 30% longer than men from the moment they begin experiencing symptoms to the time they arrive at a hospital,” Mosca said. “Once there, women experience a 20% longer wait time than men, from arrival to the moment they begin receiving care.”

But what’s the underlying cause of this disparity? While ignorance and bias might have been the most common answer in the past, there are economic forces exacerbating the inequity today, says Eli Alford, Chief Operating Officer at Elligo. “In the last twenty years, the number of doctors in the U.S. that actually do research has decreased,” he says, which causes a centralization of clinical trials to mostly the major research centers. “If you live in rural Mississippi or in a small town in Texas, are you really going to drive two hours to participate in a trial? Probably not.”

Winkfield agrees, saying the research community needs to find a way to help patients navigate around barriers preventing them from participating in research. “One of the greatest barriers people have to cancer care in general is the issue of transportation. So, if you want to be inclusive of those populations with a lower socioeconomic status, frankly, that’s going to be one of the main issues you need to address.”

There’s also a trust factor—or lack thereof—Alford says, as minority communities view clinical research with an air of caution. Blunders made by researchers—such as the Tuskegee study and Henrietta Lacks's treatment—have certainly raised questions of the research community’s intentions. “It takes time to mend those relationships,” Alford said.

Winkfield says that while wanting to mend relationships is the main goal, how one goes about it is crucial. “You have to be thoughtful, and that’s where cultivating an environment that insists upon and welcomes diversity of thought is important,” she said.

That’s where Winkfield hopes the SU2C effort will help.

“This initiative is really hoping to expand access to these trials by developing new requirements, and it’ll be interesting to see how researchers respond,” Winkfield said. “The researchers that are looking for funding from [SU2C] are going to need to integrate a plan for patient recruitment and retention of minority patients.”

Winkfield says the spirit of this initiative is collaborative, using the expertise of researchers from various fields to provide well-rounded feedback to grant applicants.

“We want the committee to act as advisors if you will, to help shape these proposals,” she said. For instance, Winkfield says her focus is on community engagement. “A team may come to us with a proposal for community engagement, but their methodology might be a little skewed or they may have some questions about how to proceed. We want to be available to them as a resource.”

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