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January 22, 2019updated 25 Jan 2019 5:51am

NCI revises clinical trial protocols to expand patient access

The National Cancer Institute (NCI), a part of the US National Institutes of Health (NIH), has updated its clinical trial eligibility criteria to boost access for patients who were previously excluded.

According to, the revisions to the NCI clinical trial protocols will apply to participants suffering from brain metastases, prior and existing malignancies, HIV and hepatitis infection, and organ dysfunction.

In addition, the update is said to affect patients aged less than 18 years.

The inclusion criteria have been incorporated to the guidelines of clinical trials that are sponsored by the NCI.

Currently, the US Food and Drug Administration (FDA) is reviewing the use of protocols in trials that could support regulatory approvals for new drugs and indications.

NCI Cancer Therapy Evaluation Program associate director Jeffrey Abrams said: “NCI is extremely supportive of broadening eligibility criteria to make clinical trials more representative.

“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.”

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Prior to the revisions to the NCI clinical trial protocols, the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research offered recommendations to expand eligibility criteria for clinical trials.

ASCO president Monica Bertagnolli said: “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.

“These requirements balance patient safety with the need to make sure that clinical trial results are generalisable to the broader patient population.”

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