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In en effort to ensure that study participants are more reflective of real-world populations, the National Cancer Institute has revised its clinical trial protocols to expand access for previously excluded patients.
Jeffrey S. Abrams, MD
In an effort to ensure that study participants are more reflective of real-world populations, the National Cancer Institute (NCI) has revised its clinical trial protocols to expand access for previously excluded patients. The revisions affect potential participants with preexisting conditions in 5 categories: those with brain metastases, prior and current malignancies, HIV and hepatitis infection, and organ dysfunction, as well as patients under the age of 18 years.
The inclusion criteria have been integrated into the NCI’s clinical trial guidelines for trials that the agency sponsors. The FDA is reviewing the protocols for use in trials that may lead to regulatory approvals for new drugs and indications.
The update follows recommendations issued by the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research to broaden clinical trial eligibility criteria. The 2 groups teamed up more than 2 years ago to advance strategies to improve trial accrual, ensure optimal patient access, and maximize information learned during trials.
“NCI is extremely supportive of broadening eligibility criteria to make clinical trials more representative,” Jeffrey S. Abrams, MD, associate director of the NCI’s Cancer Therapy Evaluation Program, said in a press release. “The goal is to expand access to clinical trials and remove previous barriers for patients with preexisting conditions and we thank all those that participated in this important effort to expand access.”
Officials from the 2 organizations praised the NCI for advancing their recommendations. “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.” Jeff Allen, PhD, president and CEO of Friends of Cancer Research, said that the new criteria are important for improving outcomes in an equitable manner. “Expanding access to clinical trials is crucial for patients, particularly those that historically have been excluded.”
The NCI’s updated protocol includes template language for clinical trials, along with details from the recommendations that ASCO and Friends of Cancer Research developed. See Table for highlights.
National Cancer Institute. Inclusion/Exclusion Criteria for National Cancer Institute (NCI) Sponsored Clinical Trials. National Cancer Institute website. ctep.cancer.gov/protocolDevelopment/docs/NCI_ASCO_Friends_ Eligibility_Criteria.pdf. Published September 26, 2018. Accessed December 7, 2018.