In a world of major cancer advances, and a growing arsenal of innovative therapies, eligibility criteria for clinical trials haven’t changed in 20 years. Edward Kim, MD, chair of solid tumor oncology at Carolinas Healthcare’s Levine Cancer Institute in Charlotte, N.C., has been trying to rectify this anachronism. Kim discussed it at the American Society of Clinical Oncology’s annual meeting earlier this month, and with MedPage Today in this exclusive video interview.

Following is a transcript of his remarks:

Eligibility criteria is a big stumbling block to many people who want to participate in clinical trials. We all know the importance of clinical trials and patients out there want access to these. You hear clinicians, patients, and other groups saying, “We need more clinical trials or we need to get more people enrolled into clinical trials.” Only about 8% of the patient population that’s eligible get enrolled into clinical trials and that’s a shame because we have some fantastic clinical trials testing some novel drugs as you’re hearing here at ASCO.

Antiquated Eligibility

The problem is that we use the same antiquated eligibility criteria that we’ve been using since the 1980s and 90s, and when you write a new protocol, you’re essentially tacking onto the existing eligibility. We need to be smarter. This is not the era of chemotherapy cytotoxic drugs. This is the era of modern, targeted therapies which we are absolutely trying to test in a precision medicine way. Those same eligibility criteria just don’t equal the same patient population.

Brain Metastasis

For instance, why are we eliminating or not allowing … for instance, why are we not allowing patients who have brain metastases that are asymptomatic or stable onto trials in which these drugs penetrate the blood brain barrier and have CSF activity? It’s very ironic. We have two of those drugs that have been recently approved in lung cancer, osimertinib and alectinib, but those eligibility criteria were somewhat restrictive in some of those populations.

Magic Johnson

Additionally, if you’ve had a stage 1 prostate cancer in the last couple years, you’re not eligible for treatment in many protocols because you couldn’t have had a recent cancer in the past 5 years. Also, I don’t know Magic Johnson. I kind of wish I did, but he has HIV. I think that’s no secret to anyone. Many clinical trials don’t allow patients who have a history of HIV. So Magic Johnson, heaven forbid he get cancer and have to think about a clinical trial, would not be eligible for many of these clinical trials that are out there. This is just not making much sense. We’ve initiated an effort through ASCO and Friends of Cancer Research.

A Call for Change

We’ve initiated an effort through ASCO and Friends of Cancer Research in which we published six papers in October of 2017 which gave recommendations — real recommendations, real template language — that states how we would change these eligibility and we cover patients with brain metastases, comorbidities, prior cancers, HIV status, renal and hepatic function, and minimum age. It’s also silly that a patient who has sarcoma, who’s 15 years old, cannot enroll into an adult trial because they’re not 18, even though their drug metabolism is the same as an 18-year-old. So, we’ve made adjustments to age 12.

FDA, NCI, Industry

This is the effort that has been ongoing since 2013. Again, I feel very privileged to have helped lead some of this effort with FDA, industry, NCI, and stakeholders, the patient advocacy and we’re just getting started. We’re implementing these changes into CTEP templates as well as other protocols. Industry partners have realized that they can do this. It will allow them to get real-world patients into their data and be able to test for any additional side effects or activity. This is a win for everyone.

Patient Safety

We, of course, want to remain very cognizant of the patient safety aspect. But if you ask the patient if a creatinine that’s slightly high should exclude them from a clinical trial, let them make an informed decision. They have a cancer that has been refractory to treatment, and this may be one of their hopes to actually receive treatment that may benefit them. I think it’s always important to take that perspective.

https://www.medpagetoday.com/publichealthpolicy/clinicaltrials/73589