According to David Graham, MD, FACP, FASCO, medical director at the Levine Cancer Institute, restrictive eligibility criteria is one of the reasons for low clinical trial participation numbers – which for cancer patients in the US is approximately 3%.
The American Society of Clinical Oncology (ASCO) study released this week during the organization’s annual meeting “makes the case for universal adoption of broader clinical trial eligibility criteria,” Graham said in a statement.
The study examined 10,500 health records of advanced non-small cell lung cancer (aNSCLC) patients from ASCO’s CancerLinQ database.
Per the report, expanded criteria – such as that proposed by ASCO and Friends of Cancer Research (Friends) in 2017 to include patients with brain metastases, previous or concurrent cancers, and limited kidney function – would nearly double the percentage of patients eligible to participate in clinical trials, from 52.3% to 98.5%.
Traditional clinical trial enrollment criteria excluded 5,005 (47.7% of patients), while the only 154 (1.5% of patients) did not meet eligibility criteria using the expanded conditions, the study found.
Additionally, ASCO reported that expanded criteria would permit more women, older patients, and those with stage IV diagnoses, as well as non-smokers, to enroll in aNSCLC clinical trials.
Lead author of the study, R. Donald Harvey, PharmD, BCOP, FCCP, FHOPA, director of the Winship Cancer Institute of Emory University’s Phase I Clinical Trials Section, explained that changes to eligibility criteria “are particularly important as we step further into the era of targeted therapies, including immunotherapies, that have different safety profiles than highly toxic systemic chemotherapies.”
“Ongoing use of historic, narrow eligibility criteria based on antiquated safety concerns place potentially unnecessary restrictions on trial participants, thus making it increasingly difficult to conduct the clinical trials necessary to demonstrate safety and efficacy of new therapies,” he said in the press release.
Efforts to expand access
Based on the proposal from ASCO and Friends, the National Cancer Institute (NCI) in November 2018 changed its clinical trial protocol template to expand patient access, though, according to ASCO, it is too early to tell if the expanded criteria is being widely adopted.
The organizations initiated the joint project aimed at evolving eligibility criteria in 2016 and submitted language in August 2018 for five US Food and Drug Administration (FDA) guidance documents. The agency subsequently published four draft guidances and one final guidance addressing cancer clinical trial eligibility criteria in March of this year.
The Response Assessment in Neuro-Oncology – Brain Metastases (RANO-BM) group, an international, multidisciplinary group working to develop standard response and progression criteria for clinical trials, also in early 2018 published new guidelines describing how to address cancer patients with CNS involvement in anti-cancer drug studies.
The lead author told us at the time that the guidelines were developed in response to the “inappropriate exclusion” of patients whose cancer has spread to their brain, but which wouldn’t affect the study’s outcome.