To protect all of us from Covid-19, we need new medicines—but especially new medicines that work for the people suffering most from this disease.
By now we know the harsh truth, that minorities around the U.S. are three times more likely than non-Hispanic whites to become infected with the novel coronavirus—and twice as likely to die from it, according to data from the Centers for Disease Control and Prevention. When adjusted for age differences, Hispanics and African Americans have been hospitalized due to Covid at rates four to five times higher than whites.
Part of the solution to these disparities must be targeting medical innovation to communities hit the hardest. Pharmaceutical companies are rapidly developing potential treatments for Covid, studying more than 400 therapies by testing them in people in more than 1,200 clinical trials.
But to make sure these treatments help minority patients, the pharmaceutical industry must do a better job enrolling minorities in those clinical trials. This has been a longstanding problem in our industry, and we all need to step up our efforts to change this.
Minorities make up nearly 40 percent of the U.S. population but less than 20 percent of participants in the key clinical trials that lead to the approval of new medicines, according to a 2015 study. This low participation is itself a health disparity because clinical trials give patients access to care and hope for healing. There are more than 30,000 clinical trials across all diseases going on nationwide now.
Yet greater diversity in clinical trials is also critical to ensure any new medicines are truly effective and safe, not just for some patients but for all. We’re encouraged Rep. Diana DeGette (D-Colo.) and Rep. Fred Upton (R-Mich.) are focusing on clinical trial diversity in a second version of the 21st Century Cures Act. DeGette and Upton propose that Medicare make it easier for seniors to participate in clinical trials by allowing them to get their clinical trial and their routine care at the same health care facility. They also suggest that Medicaid beneficiaries with life-threatening conditions, like Covid-19, receive the routine care of a clinical trial for free.
Both these ideas make sense in principle. They would build on Congress’ existing requirement that all clinical research funded by the National Institutes of Health include minorities, and on guidelines the Food and Drug Administration issued last year.
Even without that legislation, though, there are things pharmaceutical companies can do, right now, to reduce barriers and enroll more minorities in clinical trials. They include:
Locate clinical trials closer to patients’ homes. Clinical trial sites for the Covid-19 therapies should operate in cities with large populations of minorities disproportionally affected by the disease: New York City, Chicago, New Orleans, Los Angeles, Detroit and Houston, among others.
Use more virtual visits. Clinical trial check-ins via video chat can reduce time and travel burdens for patients.
Collect less data. Clinical trials often involve many diagnostic tests and data collections from participants, in the hopes that these will be useful in some way. They rarely are, but the extensive testing creates a barrier to many people participating in trials. Instead, we should focus trials to gather only the data needed to thoroughly meet our scientific objectives.
Reduce eligibility requirements. The ideal way to study the impact of a medicine is to give it to patients with no other illnesses than the one being tested. So pharmaceutical companies often exclude patients that have additional conditions. This can disproportionally exclude minorities, who have multiple health conditions at higher rates than whites.
These efforts are all works in progress, but we’ve already seen them make a difference at our company. Among the most recent 12,000 U.S. patients Eli Lilly and Company has enrolled in clinical trials, 39 percent were minorities—roughly the same as among the U.S. population. Hispanics were 18 percent and African Americans were 11.5 percent of our clinical trial patients, compared with 18 percent and 13 percent in the U.S. population, respectively.
The overall numbers still leave gaps. Lilly signs up high percentages of minority patients in our diabetes clinical trials, since diabetes is more common among minorities. But we don’t do as well in migraine or cancer. So there’s more that we and our peers can do. Our industry is committed to working with Congress on efforts to make sure all people are represented.
The coronavirus pandemic has demonstrated that when any of us is at risk, we all are. Greater diversity in clinical trials can help defeat Covid-19 for everyone.