Giving Compass' Take:
- Diane Mapes explores how advocacy for equity and inclusion is spurring efforts to streamline cancer clinical trials and loosen up eligibility criteria.
- Given that common comorbidities disproportionately affect Black, Indigenous, and Latino populations, how do overly exclusionary eligibility criteria exacerbate health inequities?
- Read more about how to boost cancer clinical trial participation.
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The good news? Enrollment in new cancer therapy clinical trials has returned to normal, at least within one large trial network, a year after the pandemic began.
The bad news? Normal trial enrollment isn’t that great.
Many close for lack of patients. Others slow to a crawl as scientists scramble to find additional volunteers, leading to longer trials, higher costs, delayed results and less reliable data. Size matters in science. The more people in a trial, the more reliable the data scientists collect. And the more people who qualify, the higher the likelihood the study will reflect the real-world population that will eventually use a new drug or therapy.
But far too many cancer patients can't participate due to overly restrictive trial criteria, say leading cancer organizations and scientists like Dr. Joseph Unger of Fred Hutchinson Cancer Research Center, whose new study in JAMA Network Open showed there was little evidence of enrollment reductions to treatment trials during the entire first year of the pandemic.
Forget COVID-19, it’s the eligibility criteria that keeps most cancer patients out of trials, limiting both access and representation by routinely rejecting older patients; patients with additional health conditions like diabetes, heart disease, hepatitis, HIV or other cancers; or those who have poor “performance scores,” a measure of physical functionality.
Patients with brain metastasis — stage 4 cancer that’s spread to the brain from its original location — still can’t enroll in most trials. Ditto for those without “measurable disease”: Researchers need to be able to see and measure the cancer so they can tell if a treatment is working or not. Tumor too small or not capable of being imaged? You’re out. Too many lines of treatment? Sorry, you don’t qualify either.
Patient safety is at the heart of most exclusions, but too-tight criteria end up keeping out the patients most in need and exacerbating existing cancer health disparities. Comorbidities, or additional diseases, like heart disease and diabetes are more prevalent in Black, Hispanic/Latino and Indigenous populations.
Read the full article about cancer clinical trials by Diane Mapes at Fred Hutchinson Cancer Research Center.