The National Cancer Institute (NCI) updated its clinical trial criteria to allow patients with specific health concerns to participate in NCI-funded clinical trials, as well as provide opportunities for patients younger than 18 years to take part in adult cancer trials.
“NCI is extremely supportive of broadening eligibility criteria to make clinical trials more representative,” said Jeff Abrams, MD, associate director, Cancer Therapy Evaluation Program, NCI, in a press release (December 4, 2018). “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.”
The updates are a reflection of recommendations from the American Society of Clinical Oncology and Friends of Cancer Research, which helped identify areas where eligibility criteria are likely to restrict a patient’s participation, but not likely to impact the safety of participants.
Expanded criteria feature inclusion of individuals with pre-existing conditions – including brain metastases, HIV/AIDS, chronic hepatitis B, organ dysfunction, and prior and concurrent malignancies. Protocols submitted to the NCI Cancer Therapy Evaluation Program after November 1, 2018, are expected to adhere to these eligibility requirements.
Furthermore, the expanded criteria is expected to build on NCI’s efforts to support precision medicine and potentially lead to precision medicine breakthroughs.
“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 are applied in routine clinical care,” said Monica M Bertagnolli, MD, FACS, FASCO, president, ASCO, in the press release. “These requirements balance patient safety with the need to make sure that clinical trial results are generalizable to the broader patient population.”