FDA issues three new guidances to expand eligibility criteria for cancer trials

The FDA's Oncology Center of Excellence has released three final guidance documents aimed at widening the pool of patients who can enroll in oncology clinical trials.

The guidances focus on three key eligibility factors, a patient's performance status, the range of acceptable laboratory test results, and the required washout periods between prior therapies, with the goal of reducing unnecessary exclusions.

By encouraging broader and more diverse enrollment, the FDA hopes the changes will help generate trial data that better reflect real world patient populations, though the recommendations are non-binding.