Cancer Trials: US FDA Guidances Aim To Expand Eligibility Criteria And Better Inform Labeling

 
• By Sue Sutter

Draft guidances reflect the agency’s thinking on when patients with HIV/hepatitis infection, brain metastasis, organ dysfunction or prior malignancies, as well as pediatric patients, should be enrolled in cancer trials; FDA also finalizes recommendations on adolescent enrollment in adult studies of oncology drugs.

The US FDA’s push to open up clinical trials to a broader, more diverse group of patients took a big step forward with the release of four draft guidances and a final guidance aimed at eliminating unnecessary exclusionary criteria in cancer studies.

The suite of draft guidances on cancer clinical trial eligibility criteria reflects the agency’s current thinking on when cancer patients...

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