A Close Look at Clinical Trials in Oncology and Beyond: Recruitment and Inclusion

In this episode of OncChats: A Close Look at Clinical Trials in Oncology and Beyond, Christina Brennan, MD, MBA, FACRP, and Richard D. Carvajal, MD, of Northwell Health and Northwell’s Feinstein Institutes for Medical Research, highlight the increasing push to simplify cancer trial eligibility criteria and improve diversity in participant enrollment, stressing the importance of making clinical research more accessible and inclusive—especially for underrepresented populations.

Brennan: Yeah, and given the complexity of these protocols, are you finding it harder to find eligible patients who meet the criteria?

Carvajal: I think the good news is that there is a clear recognition across the field in the industry that these therapies have to be made more accessible. And so, [when it comes to determining] what inclusion and exclusion criteria are really important, we will verbally state that we have to keep it as lenient as possible. There’s a major effort in the cancer field. You mentioned ASCO. So ASCO [and] Friends of Cancer Research, they’ve published a big position paper stating that things have to be simpler, but the FDA is doing the same thing. Why are we excluding patients with brain metastases? Why does it matter if they had some relatively slow-growing cancer 3 years ago? Why are those patients excluded? Honestly, they shouldn’t be.

Brennan: Yeah, and if you look at that, why did it take until 1993 to have conversations to make sure we were including women after the Revitalization Act? Why did it take until 1993 [for that change to happen]? It’s crazy. Women and men behave differently [with regard to] their bodies, and not everything can be approved for one sex.

Carvajal: Yeah, and that brings up the need for racial/ethnic and socioeconomic diversity [when it comes to trial] enrollment. I’m so excited that this has at least become top of mind for everyone; [there’s an acknowledgment that] this is critical.

Brennan: I agree. The FDA is focusing on this; there are separate offices in the FDA that are focused on diversity, equity, and inclusion. We have to continue to talk about it and to ensure that these patients are included, and that we’re doing a good job, as well.