Minorities tend to participate in clinical trials at far lower rates than their real-world demographics and prevalence of the disease, according to the American Society of Clinical Oncology. In addition, minorities often have worse outcomes for certain cancers than the broader public. For instance, the mortality rate for Black women with breast cancer is 40% higher than that of white women.
The pandemic, however, has highlighted persistent health disparities while offering potential strategies for improvement, according to Amy Davis, senior director of clinical development at Lilly Oncology.
The pandemic has popularized the use of decentralized trials. For instance, Lilly debuted decentralized capabilities in a recent breast cancer trial and will continue doing so for upcoming trials. “We are building in decentralized capabilities from the get-go — decreasing the number of in-person visits by half,” Davis said. The company is using remote data capture and offering more telemedicine visits to optimize enrollment. Lilly is also aiming to identify strategies to simplify how patients receive scans and lab testing.
Amy Davis
When working to expand decentralized trial capabilities, companies like Lilly are also forced to confront the digital divide and varying expectations from clinical trial participants. “Not every group of patients is going to want people in their home or want to do virtual visits,” Davis said. “It is going to be a delicate balance. I think we’re going to need rapid learning cycles to understand what’s working and what’s not.”
The beauty of decentralized trials is that they enable drug developers to reach new patients in rural areas or urban areas who may not live close to an academic medical center. “Having decentralized trials allows these patients to participate in research and allows us to have more diversity because as a result,” Davis said.
The pandemic has also resulted in a greater collaborative focus on diversity across the industry, regulatory agencies and advocacy groups.
For instance, Lilly is now working with the decentralized research organization Care Access Research (Boston) to help reduce the barriers of entry for oncologists and other specialists in remote areas who are interested in enrolling patients in clinical trials. Care Access also offers a geo-mapping service to find concentrations of patients who currently lack an option to participate in clinical trials.
The work with Care Access “helps twofold with our goals,” Davis said. “We not only want to increase the diversity of patients in our trials, but we also want to increase the diversity of the investigators we’re working with. And so this allows us the opportunity to do both.”
Lilly is also partnering with the clinical optimization software company Reify Health (Boston) to screen patients interested in joining new clinical trials. The partnership helps Lilly keep tabs on the diversity of such patients while also keeping track of why potential participants are screening out. The latter can inform the inclusion criteria of future clinical trials to optimize for diversity. “Reviewing eligibility criteria is critical because we know that minorities are more likely to have multiple health conditions than whites,” Davis said. “So if you’re excluding folks who have other health conditions by default, you’re disproportionately excluding [diverse] populations.”
In the long run, Davis said the pharmaceutical industry must continue to confront a handful of themes to continue making progress in clinical trial diversity. “The first is addressing lack of trust,” she said. “You build trust through working with more physicians and investigators who look like the patients you’re trying to recruit,” she added.
The pharmaceutical industry also needs to continue to reduce the barriers to clinical trial access through decentralization and other strategies. “We’re going to have to locate trials where patients are and offer more virtual visits, so people don’t have to travel or take time off of work or have an unnecessary burden,” Davis said.
Another way the pharmaceutical industry can build stronger relationships with diverse populations is through partnerships with advocacy organizations and trusted intermediaries. “One of the things that we learned in COVID is that you have to go to your churches, you have to be on radio stations that these populations listen to, and you have to be with their local health care providers and those trusted intermediaries in their community,” Davis said.