Dr Ruben Mesa on Diversity and Inclusion in Clinical Trials for Rare Diseases

It can be particularly difficult to include a diverse group of patients in clinical trials for rare diseases, but doing so is important to ensure that treatments are effective and safe across populations.

In many situations, clinicians need to fill gaps when enrolling patients with rare diseases in clinical trials, says Ruben A. Mesa, MD, president and executive director of Atrium Health Levine Cancer Institute and Atrium Health Wake Forest Baptist Comprehensive Cancer Center.

This transcript has been edited for clarity.

Transcript

With your background in leading a National Cancer Institute (NCI)-designated cancer center, how do you plan to incorporate diversity and inclusion into clinical trials and cancer research efforts to improve outcomes for underrepresented patient groups?

I think inclusive clinical trials really start before patients are eligible for a study. It really is engaging with community and groups to build trust. There have been clear examples in the past where trust was violated, as it related to the conduct of clinical research. So in many ways, we start in a hole with many populations and try to work past that; build trust in areas of prevention and screening. Of course, with clinical trials, it is crucial.

Second, the clinical trials have to be feasible. I sit on many different national discussions around these issues and the more visits and the more complex it is to participate, and the more individuals have to travel a distance to participate, the greater the burden becomes, the less likely it is that people will participate. So much included in terms of the design of the study, as well as whether it's a centralized or decentralized trial, and even the eligibility criteria sometimes can be inadvertently exclusionary by penalizing populations where we see higher rates of baseline increases in liver function tests, or mild renal insufficiency. Trying to limit eligibility criteria to those issues that are truly most important is crucial.

As health care systems continue to merge and expand, how do you envision the role of multidisciplinary care teams and collaboration in delivering value-based cancer care at Atrium Health?

Multidisciplinary care and interprofessional care is really essential. If we take prostate cancer for an example, again, there are multiple options, sometimes for certain prostate cancer patients between radiation therapy, or surgery, or even observation. A multidisciplinary team that is able to look at the full impact of the cancer on the patient, the current evidence, who try to really elucidate for the patient all the appropriate outcomes, so that we have the appropriate utilization. And that has implications both in terms of the patient's health, in terms of outcomes, in terms of the health care resources that are necessary, as well as long-term implications for the patient.

We're better as a team than we are as individual sub-specialties. There's the old adage, "If you go to a barber, you're gonna get a haircut." Multidisciplinary teams bring in multiple perspectives, that combined with the current evidence, really are able to provide the best overall balanced care. And it's circumstances where we truly have more than one option—prostate cancer again, is an example of that—there's a case to be made for radiation, there's a case to be made for surgery. Again, the patient needs to be part of that decision making. In a multidisciplinary team, they can hear from experts in each of the areas to be able to weigh their options in the best way.