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

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 with other comorbid conditions – such as HIV/hepatitis infection, brain metastasis, organ dysfunction and prior malignancies – should be allowed to