Increasing diversity in trials is a goal for researchers in most therapeutic areas. Unfortunately, cancer trials lag even further behind in representation, and the lag could have dire consequences for the communities in question—for example, the mortality rate for Black women diagnosed with breast cancer is 40% higher than for white women.
According to Eli Lilly, their efforts to boost inclusivity in recruitment appear to have paid off—among the most recent 12,000 US-based patients enrolled in the company’s trials, 39% were from minorities, about the same as the overall US population. Still, they have not had the same impressive recruitment results in oncological studies.
Outsourcing-Pharma spoke with Amy Davis, senior director of clinical development for oncology with Lilly Oncology, about the company’s strategies to increase representation, and the key components of a successful strategy to increase minority participation in cancer trials.
OSP: Could you please tell us a little bit about you, and your work with Lilly?
AD: I’ve been at Lilly for more than 20 years. I have accountability for the planning and execution of all of our late-stage or late-phase trials within the oncology portfolio. In addition to that, I helped to lead the corporate-wide initiative that we're doing related to diversity inclusion and clinical trials.
Obviously, oncology is an area of focus, but we also have other focus and therapeutic areas in which we do business. We’re leading those efforts more broadly and putting together our strategy, where we're going to focus and think about the different tactics we're going to use to enhance the efforts that we've had going on for the last decade.
OSP: What are some of the risks inherent in failing to achieve sufficiently inclusive patient recruitment for an oncology trial?
AD: In oncology and other areas, we know that diverse representation in our trials is critical because it helps our researchers to understand ultimately how our drug is going to work in any possible patient that could use them. We know patients respond differently based on race, ethnicity, sex, age—a multitude of factors.
We also know that treatment decisions that are made by physicians for individual patients rely on this data; it also contributes to broader health initiatives that are designed to improve health equity and create better outcomes for all patients. I think one of the compelling numbers is that minorities make up about 40% of the population in the US, and they constitute in clinical trials about 36% of participants in trials, but the percentage of minorities that are represented in oncology clinical trials is only 27%, so it is lower.
That’s driven by a multitude of factors. It can be access to quality health care, socioeconomic challenges, discrimination, trust issues that have long stemmed from issues that have happened in the past, and less access to health care. If you have less access to health care, you're going to have less access to a physician that could link you as a patient volunteer to clinical research so. That’s why it's important and why everybody needs to be focused on this.
OSP: Could you please talk about your overall strategy and lessons learned along the way?
AD: There are really three key pieces to our strategy, and this will be for Lilly Oncology and for all of the areas within Lilly, as we think about enhancing diversity.
The first is to create robust clinical trial strategies to reach diverse populations. This is everything from the design of the trial upfront as you think about inclusion-exclusion criteria, schedules of events, how we're using decentralized capabilities, all the way through the execution of the trial. Our goal is to have our participants match the composition of the US population who would ultimately use that drug, based on the prevalence rates in the US.
The second thing is to intentionally select a more diverse group of trial sites and of investigators. We know that people are more likely to be treated by people that live in their areas or are like them.
We’re intentionally doing things to enhance the diversity of our advisors and the investigators that that run our studies. We’re doing a lot of things to enhance areas that aren't necessarily covered by traditional sites. We’re looking at how we use decentralized capabilities, and at how we look for physicians who are interested in research that may not have had the right foundation around them to become researchers and helping them to become researchers.
The third is partnerships and collaborations; we're partnering with patient groups, patient advocacy groups, regulatory agencies, healthcare professionals, and community organizations, to identify and implement solutions.
We have ongoing trials in breast cancer. We’ve started some new breast cancer trials, and we're going to have more starting. We know that Black women that are diagnosed with early breast cancer have a 40% higher mortality rate than white.
We also know that there's about a 16% prevalence rate of breast cancer in the Black community, but only about 3% of those patients are represented in clinical trials. This is obviously an opportunity. We know they have worse outcomes. We know that they’ve not historically been represented.
One of the things that we're doing right now is conducting an African American clinical trial patient journey, to understand barriers for enrolling and entering into trials, as well as working with minority research advisory groups.
We've partnered with advocacy groups, like Tigerlily, where we've brought them in from the very beginning to look at our protocols. They are a group that works as an advocacy organization for Black women with breast cancer. Bringing those groups in early on, having them review our protocol to say, “Are there things in that protocol, the way it's written, that would inadvertently exclude Black women from wanting to be in this trial?” They're helping us all the way through recruitment.
We're also using technology. We've got partnerships with external groups for site-facing technology that a lot of sites use today in and outside the US, to use for pre-screening of patients for trials. We’re looking at that data and adding in race and ethnicity data so we understand that the volume of patients, or the diversity of patients that these investigators are considering, and we also can understand why patients are screening out. That could help us as we think about future protocol design
Those are some very tactical things that we're doing in our breast cancer studies that will quite frankly replicate in other areas of oncology, and also in other areas that Lilly does research.
A couple of things I would note in collaborations: we've been working with a national minority equality forum. This past June we jointly published a white paper around opportunities to improve quality and advance equity along the cancer care continuum. This has a lot of solutions listed in it that stakeholders across the various aspects of healthcare can leverage help to promote reforms. One of the recommendations is obviously increasing clinical trial diversity, but also there are things like enabling earlier detection of cancer, breaking down barriers to access oncology care, and others.
Hot off the presses: today we announced a partnership with the Susan G. Komen Foundation. It’s going to focus on three key areas to bring immediate and sustainable support to the Black community. This will work in three areas, expanding their culturally competent patient navigation program in three cities. Those key cities will be Chicago, St Louis, and Indianapolis, helping them to hold the inaugural Navigation Nation, which is a patient navigation summit that will occur in 2022 and support their breast care helpline. There’s more to come on that front.
Certainly, you can see there are things that we're doing, through the way we're designing our trials and the selection of our sites and investigators, but also through strategic partnerships and collaborations to do what we can to move the needle.
OSP: Do you feel that efforts to increase inclusivity fall short, or that they're not getting where they need to be?
AD: We’ve been focused on this for more than a decade, and we have even further enhanced our efforts, and a lot of folks across the industry, post COVID. We saw the disparities that already existed even further exacerbated in some of these populations.
We're all trying new things, and we're all learning from each other. We participate in several cross-industry collaboration groups where we share best practices and learn from each other. We've always had our materials available in different languages. But we’re even thinking about the imagery used in the materials that are presented to patients, so they see patients that look like them, and that we’re going to places that are trusted community places, where these folks will get information right. We’re thinking about things like how to get information out through other sources, and through local community care centers.
We’re going to try a lot of different things. Some of those are going to work, some aren't. I think the key for all of us, not only internally but across all the groups that are trying to really move the needle here, is to have rapid learning cycles. What are the things that work, what aren't working?
That's why you really got to have that broad collaboration. It can't just be pharma; it's got to be your advocacy groups, patient groups, CROs, regulatory agencies, policymakers. It’s going to take all those groups working together.
I don't think anybody has perfected this; if we had we'd be where we'd want to be, and we're not. But I think there's a lot of good efforts that are going on at Lilly and other places to make a difference.
It’s not going to be a one-size-fits-all for every population. It's not going to be a one-size-fits-all for every disease, either. We're going to have to continue to try a broad group of things to see what hits the mark. We need to replicate quickly where we can the things that are working.
OSP: Are you optimistic that truly inclusive clinical research is within the industry’s reach?
AD: It’s going to take work to move the needle, but I am optimistic. More so than ever before, we're seeing a wider collaboration amongst healthcare companies, advocacy, regulatory agencies, policymakers—this is top of mind for everyone. We’re going to see more traction. Is it going to change overnight? No. We’re going to have to continue to have focused efforts and connections across all those groups.