“We feel we cover what the FDA is asking for,” because the ethnic makeup of Novo Nordisk’s U.S. trials generally mirrors the 2010 census, says Kate Owen, the company’s vice president of clinical trial management. “That being said, we still felt we could do better.”
So now Novo is piloting a program in Washington, DC, aimed at boosting the population of minorities in its clinical trials for drugs to treat type 2 diabetes. It’s a multi-pronged plan that involves reaching out to community health clinics and other providers that don’t normally participate in clinical trials, and educating physicians about the benefits their patients might reap from volunteering for research. “We have an opportunity to improve how we reach out into the community,” Owen says.
With its new program, Novo is answering an increasingly urgent call from regulators, physicians and patient-advocacy organizations that want to know how new drugs affect more than just the average Caucasian, male patient. These health providers are demanding details about how drug response differs not just by racial group, but by gender and age, as well.
The need to better reflect the makeup of the patient population is particularly pronounced in diabetes. African Americans make up 13% of the total population, but their participation in clinical trials for type 2 diabetes products was less than 5% in 2011, according to an FDA report. This despite the fact that African American adults are 70% more likely than non-Hispanic white adults to be diagnosed with diabetes, according to the U.S. Department of Health and Human Services.
Homogeneity is an issue in clinical trials for other diseases, as well. A review published last year in the journal Cancer reported that virtually all ethnic groups were under-represented in cancer clinical trials when compared to the proportion of the general population that they represent. In combing through 86 randomized trials published in 2009, the authors discovered that 57% of the papers reported sample sizes according to demographic group, but only 36% actually analyzed the results by race or ethnicity.
Oncologist and lead author Moon Chen says part of the challenge of recruiting minorities for clinical trials is that pharmaceutical companies and physicians are often insensitive to cultural influences—which can powerfully sway patients’ opinions of medical research. “For example, Chinese people traditionally do not like to give blood because blood represents life,” says Chen, professor and associate director of population research and cancer disparities at the University of California Davis Comprehensive Cancer Center. “But there’s another value Chinese people have, which is doing something for the next generation. So when we ask for blood samples for cancer research, we can tell them they’re doing something to help the next generation.”
Moon recommends that pharmaceutical companies interview minority physicians and include people from a variety of ethnic backgrounds in focus groups, so they can better understand cultural influences on decision-making—and then use those insights to improve how they recruit trial patients.
Novo’s Owen says that trials for obesity products also offer diversification opportunities. African Americans represent 40% of the U.S. obese population but only about 15% of trial participants, she says. Problem is, many patients aren’t comfortable receiving medical care beyond their community clinics. So Novo has been providing educational materials to physicians in its existing clinical trial sites, which they can take to local clinics or health fairs to give to patients they might not otherwise see. The idea is to educate potential patients about what participating in a clinical trial is like, Owen says.
“This isn’t about Novo Nordisk, it’s about general communication to a greater community,” she says. “If any patients express interest, then they will be approached by our clinical trial sites.”
The FDA is encouraging companies to be proactive in diversifying their clinical trials, even releasing an action plan last August for collecting data on demographic subgroups. The plan got mixed reviews from patient advocacy groups, many of which said it didn’t go far enough to incentivize companies to actually follow the recommendations.
“Leaving flyers at community health centers isn’t enough. Companies need to find physicians who treat the patients in the groups they’re targeting, so they’re being recruited by physicians they trust,” says Diana Zuckerman, president of the National Center for Health Research, a think tank in Washington, D.C. “If a company has a drug that’s only being studied on white men, that drug should only be approved for white men. If [the FDA] does that, I promise you the companies will find ways to recruit other people.”
No doubt there will be some risk to companies that slice-and-dice their data according to demographic differences. That became clear in 2013, when the FDA lowered the recommended dosage for women taking Ambien (zolpidem) after the agency was flooded with reports from women complaining of next-day drowsiness. Turns out after-market studies showed that women metabolize the drug more slowly than men do, raising the risk of side effects.
By the time the FDA issued its new recommendations, Ambien had gone generic, making the impact on its inventor,
“The FDA knew there were problems with insomnia drugs for years, yet millions of women were taking those drugs at doses that were dangerous for them,” Zuckerman says. “Women metabolize some drugs differently. The same may be true of racial and ethnic groups.”
Novo Nordisk will spend the rest of this year evaluating its pilot program to determine whether it should roll out its diversity initiatives more broadly, Owen says. Success won’t come easily, she suspects. “With any clinical trial participant there has to be a level of trust in the caregiver who’s going to enroll you and treat you in that clinical trial,” she says. “Perhaps there isn’t as much trust as we need at this stage.”
