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.
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.”
Table. Highlights of Inclusion Guidance for Clinical Trials
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.”
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.
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