Q&A: Eli Lilly is making strides in overall trial diversity, but oncology lags behind

Eli Lilly has made strides in increasing the diversity of clinical trials overall, but, when you zoom in on oncology, people of color continue to be left out.

The Indianapolis Big Pharma has reached a rate of about 39% minority participation across its portfolio of trials that covers 12,000 patients in the U.S. But that rate dips to 11.5% for African Americans and 18% for Hispanic and Latinx populations when cancer is singled out. Amy Davis, senior director for oncology clinical development, wants the company’s trials to better reflect the unique disease populations in oncology.

Here are just a few stats on how cancer affects people of color differently: Black women with breast cancer have a 40% higher rate of death than white women. Black men are two times more likely to be diagnosed with prostate cancer than white men and two times more likely to die from the disease. Davis argues that clinical trials must do a better job of matching the disease burden to the patient population for each indication. 

Lilly’s overall diversity strategy is to address a lack of trust in medicine, reduce barriers and establish community partnerships to boost minority enrollment in clinical trials. Some key elements are recruiting trial investigators of color so patients see someone who looks like them. Lilly also wants to bring trials to patients through decentralized clinical studies, virtual visits and other digital strategies.

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But cancer needs a unique approach. Read on for more on how Lilly is looking at diversity in oncology trials differently.

The following interview has been lightly edited.

Amy Davis (Eli Lilly)

Fierce Biotech: Can you walk me through the situation with cancer trials specifically, and why they are not seeing an increase in diversity?

Amy Davis: Cancer really hasn't caught up to other indications when it comes to trial diversity. Although minorities make up about 40% of the U.S. population, they only constitute about 36% of participants in those key clinical trials that lead to new medicine approvals. We know that percentage is even lower in oncology, where we typically have about 27% of minority participants in clinical trials.

People of color often experience barriers to accessing quality healthcare, either driven by socioeconomic challenges or bias and discrimination in medicine, and so people who have less access to healthcare have less access to doctors who would typically be the individuals who would connect these patient volunteers into clinical research.

FB: Lilly has enrolled about 40% minorities across your trials, which matches the U.S. population, but when you think about the disease burden for certain cancers, is that the correct ratio?

AD: We know that about 16% of the population of women who have breast cancer are brown and Black women, but historically only about 3% of those patients come into clinical trials. While our numbers were somewhat higher than that in our trials overall, our goal is to recruit patients who are consistent with the U.S. prevalence of those diseases for those populations.

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FB: What's the benefit to having more diverse trial populations?

AD: Patients respond differently based on race, age, sex, ethnicity, a multitude of factors. And so it's important for us to investigate our drugs in the patients who ultimately may use our medications when they come to market.

FB: There are some bigger issues at play here, so what do you see as some solutions that we can do quickly, and what are some longer-term ideas?

AD: We're conducting an African American oncology clinical trial participant journey to understand barriers to entering trials. We're also working with Black, African American and Hispanic/Latinx advisory groups to help us as we think about our trials.

The second thing we've done is partner with advocacy groups that specifically work with women of color and support women of color with breast cancer. We've had them work with us from the beginning of our protocol design to look at things like our inclusion/exclusion criteria, our schedule of events and some of the decentralized capabilities that we're building into the study to make sure there aren't things that we're doing from the design perspective that are going to exclude women of color inadvertently.

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Lilly has specific goals related to enhancing the diversity of investigators in addition to patients. We’re working with groups that go out into the community and find oncologists who perhaps don't work in a large institution or don't have the staff to do clinical research but are interested. We want to help those individuals become investigators in our trials and therefore serve patients in areas that may not have traditional oncology sites.

FB: When you look at your peers in the industry, are they seeing a similar challenge to increase diversity in cancer clinical trials?

AD: This is not an area that is unique to Lilly. The healthcare system overall is a very interconnected ecosystem, and the issues with inequality have to be systemically changed. You're starting to see even wider collaborations between healthcare companies, advocacy groups, regulatory agencies, policymakers and patients to really further clinical trial diversity.