We Need to Lower Barriers to and Burdens of Trial Entry: Dr Andrew Hantel

Andrew Hantel, MD, faculty member in the Divisions of Leukemia and Population Sciences at the Dana-Farber Cancer Institute and instructor in Medicine at Harvard Medical School, joined The American Journal of Managed Care^® (AJMC^®) to discuss a pressing issue persisting throughout oncology research: disparities in clinical trial enrollment.

Exploring this topic further, Hantel detailed his perspective on the current predicaments impacting oncology trial design, observable differences he has witnessed between demographic groups, and more. His research and findings were expanded upon at an event for the Institute of Value-Based Medicine: The Impact of Social and Genetic Factors in Cancer Care.

This transcript has been lightly edited for clarity and length.

Transcript

Can you provide an overview of the current state of enrollment in oncology trials? Particularly, how do enrollment rates differ among various demographic groups?

In adult oncology in the US —which is very different from children's oncology due to a number of reasons—about 5-10% of patients, based on the type of cancer, enroll in a clinical trial throughout their cancer journey. That number tends to be pretty static and low over the years, and that's because a large number of patients with cancer in the United States are treated at places that don't have any clinical trials available. They're mostly treated at community centers, and not necessarily academic centers or places that do clinical research. That's not to say that a lot of community centers don't do research. There are a variety that do, but most patients just are in places where they aren't.

Now, this has been something that we've been trying to kind of remediate through different things, like trying to expand the availability of trials in places where they haven't been before, and that kind of plays into this issue in who's available or where trials are available, and which types of patients have trials available, and then are able to actually enroll in them. And so, we can kind of think of it from the patient's perspective of, “Do I get to a place where my cancer is being treated, where there is a clinical trial? If I'm there, does my particular type and kind of therapy line up with available trials?” And then, “Am I eligible for the trial? Am I able to partake?” Because of how far away [they] live, if [they] have enough caregivers, if the cost is too high, all these things might lead [them] to say no. Or even if [they] say yes and get onto the trial, these things might lead me to have to withdraw from the trial because of the burdens that are placed on [them] because the trial participation.

And so, we see that at every step of that journey. Patients who are in minoritized groups, be it by ethnicity, be it by race, be it by gender identity, and for older adults as well, those are all kind of the groups that are affected more by each of those steps. There’s kind of a whack-a-mole, if you will, that you need to take from expanding trials in terms of locations, especially for the southeast and the southwest, for lowering those burdens and barriers to entry, like eligibility criteria, as well as the burdens on specific patients in terms of costs, in terms of driving distance, in terms of those other factors that might stop them from being able to say yes. And then you have the trustworthiness as well with who's offering the trial, taking into account the historic marginalization and experimentation of minorities groups, and our need to foster trustworthiness amongst the medical research community with those people. So altogether, that's kind of why things are the way they are today.