Cancer patients who are between treatments or are taking medications for other conditions wouldn’t automatically be left out of clinical trials under a proposal by advocacy groups to broaden the study population.

Five new recommendations published Tuesday by Friends of Cancer Research and the American Society of Clinical Oncology aim to remove hurdles to enrollment by better tailoring the criteria for who can participate in the study at hand.

Eligibility criteria transfer from study to study, sometimes in ways that make it harder for minorities or women to participate. Jeff Allen, president and CEO of Friends, noted the range of lab test results for what’s considered a reasonably healthy individual has generally centered around white males since they historically constituted the largest study population.

“That parameter might actually be inadvertently excluding individuals who still fit that healthy criteria, they just have a different biological normalcy value,” Allen said in an interview. The patients who ultimately receive the therapies tested in these trials may fall outside the parameters set up in the study.

“So how do you expand those boundaries a little bit to try and generate the information based on the population of the people who actually will be receiving the drug better?” he said.

The recommendations come amid a larger national focus on health equity as the pandemic has highlighted ongoing disparities that cause communities of color to face worse patient outcomes. Those inequities and lack of diversity have long been an issue in clinical trials, including cancer research. Black Americans made up 7% of the clinical trial population for cancer clinical trials between 2014 to 2018 that led to an approved therapy.

“Clinical trial access must be recognized as a health equity issue,” ASCO President Lori J. Pierce said in a statement. “Overly restrictive eligibility criteria without scientific justification has led to an underrepresentation of older adults, racial/ethnic and sexual/gender minorities, and patients with well-managed comorbidities.”

President Joe Biden has tapped Marcella Nunez-Smith, associate dean for health equity research and associate professor of internal medicine at Yale University, to lead a new White House task force on health equity.

Eligibility Criteria

The five areas of eligibility criteria the groups want to change include patients who have been excluded because:

·   of a washout period, or the time between the most recent treatment and trial, unless it’s scientifically justified.

·   they were on other medications, unless they won’t hurt the patient or compromise the study drug.

·   they received a certain number or type of prior therapies.

·   of lab test results that aren’t scientifically justified and don’t account for potential normal variations due to race, ethnicity, age, sex, and gender.

·   of performance status, or a reduced ability to perform everyday tasks.

The Lazarex Cancer Foundation, a Danville, Calif.-based nonprofit whose aim is to increase access to cancer clinical trials, lauded the proposal.

“For too long our cancer clinical trial system has been set up so only a privileged few have access,” Dana Dornsife, founder and CEO of the nonprofit, said in an email. “We believe this is a step in the right direction toward leveling the playing field, improving access and minority participation, and creating a stronger foundation for health equity.”

The recommendations build on a successful effort by ASCO and Friends several years ago to expand eligibility criteria to include groups who have been historically left out, such as HIV patients. The Food and Drug Administration issued guidance that incorporated their recommendations, and the National Cancer Institute made a similar expansion.

But that initial round of recommendations largely stemmed from outdated perceptions and data that no longer make sense, such as automatically rejecting anyone who’s HIV positive, Allen said. The new set will likely require some degree of clinical judgment as to whether the exclusion criteria are unnecessarily restrictive.

The FDA’s internal experts participated in some of the working groups for both rounds of recommendations.

“Our intention is to continue dialogue with them about what would be appropriate moving forward,” Allen said. “I think that everyone thought this was a productive and useful step toward implementation. And so hopefully we will be able to explore those types of activities with this next round of recommendations as well.”

While some of these categories may apply specifically to cancer, such as performance status, Allen said he hopes they help to make clinical trials more accessible across the board. “I don’t think it’s an issue that is unique only to oncology,” he said.

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