The National Cancer Institute (NCI) has revised its clinical trial protocol template to expand eligibility criteria for cancer clinical trials. The updated criteria will allow patients with certain health conditions to participate in NCI-funded trials, as well as provide opportunities for patients younger than 18 to take part in adult clinical trials under certain circumstances.
The new guidance offers expanded criteria for individuals with pre-existing conditions, including brain metastases, HIV/AIDS, chronic hepatitis B, organ dysfunction, and prior and concurrent malignancies. New protocols submitted to NCI’s Cancer Therapy Evaluation Program (CTEP) on or after November 1, 2018, will be expected to use these eligibility requirements.
“NCI is extremely supportive of broadening eligibility criteria to make clinical trials more representative,” said Jeff Abrams, MD, Associate Director of the Cancer Therapy Evaluation Program, NCI. “The goal is to expand access to clinical trials and remove previous barriers for patients with pre-existing conditions and we thank all those that participated in this important effort to expand access.”
These updates follow recommendations from the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research (Friends). The two organizations identified areas where eligibility criteria were most likely to restrict a patient’s participation, but least likely to impact the safety of participants, including certain conditions and minimum age.
“We commend NCI for their recent effort to expand clinical trial eligibility criteria based on the recommendations put forth by Friends and ASCO earlier this year,” said Jeff Allen, PhD, President and CEO, Friends of Cancer Research. “Expanding access to clinical trials is crucial for patients, particularly those that historically have been excluded. We applaud NCI’s efforts to encourage the inclusion of more patients.”
These expanded criteria will build on NCI’s efforts to support precision medicine and increase participation in cancer clinical trials. In July 2018, the organization launched the NCI and VA Interagency Group to Accelerate Trials Enrollment (NAVIGATE) to enhance veterans’ ability to take part in cancer research.
NAVIGATE aims to help researchers identify studies that may be of interest to veterans with cancer and provide the funding necessary for veterans to access promising cancer treatments locally.
With these updated eligibility criteria, NCI will further increase participation in cancer clinical trials and improve care delivery for all types of cancer patients.
“By expanding its clinical trial eligibility requirements, NCI is helping to ensure that participants in clinical trials better reflect the patients who will eventually receive cancer therapies once they’re applied in routine clinical care,” said ASCO President Monica M. Bertagnolli, MD, FACS, FASCO. “These requirements balance patient safety with the need to make sure that clinical trial results are generalizable to the broader patient population.”