The National Cancer Institute broadened the criteria for participation in NCI-funded clinical trials after meetings with cancer research organizations and the FDA. The new criteria expands eligibility to include patients with brain metastases, HIV/AIDS, chronic hepatitis B, organ dysfunction and a history of hepatitis C or cancers beyond the trial’s target. It also removes barriers for patients under 18 to enroll in trials, which the FDA has said previously is a priority in promoting trial diversity.
The American Society of Clinical Oncology and Friends of Cancer Research advised NCI and provided recommended language. By broadening the possible patient pool, “NCI is helping to ensure that participants in clinical trials better reflect the patients who will eventually receive cancer therapies,” said ASCO President Monica Bertagnolli in a statement applauding the move.