The following is a message from the Director of the FDA Oncology Center of Excellence, Dr. Richard Pazdur:

On April 26, 2024, the Food and Drug Administration issued three draft guidance documents on eligibility criteria in cancer clinical trials to address performance status, washout periods and concomitant medications, and laboratory values.
These guidances are a continuation of an effort initiated in 2017 in collaboration with the American Society of Clinical Oncology and Friends of Cancer Research to broaden eligibility criteria in cancer trials. The new guidances provide FDAs current thinking on several critical eligibility categories. 

The first guidance, Cancer Clinical Trial Eligibility Criteria: Performance Status Guidance for Industry, IRBs, and Clinical Investigators, provides recommendations on expanding eligibility criteria to include patients with a wider range of performance status. 

The second guidance, Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications, Guidance for Industry, IRBs, and Clinical Investigators, provides recommendations on the appropriate use of washout periods and concomitant medication exclusions. 

The third guidance, Cancer Clinical Trial Eligibility Criteria: Laboratory Values Guidance for Industry, IRBs, and Clinical Investigators, provides recommendations for selecting appropriate laboratory values as trial eligibility criteria to avoid unjustified exclusions of diverse trial participants. 

Fostering efficient and more patient-centric clinical trial designs has long been a priority for the FDA’s Oncology Center,” said Paul G. Kluetz, deputy director of the FDA’s Oncology Center of Excellence. “Assuring that eligibility for a cancer trial is not overly restrictive can facilitate enrollment of a more diverse and “real-world” group of patients that are more reflective of who will use the therapy in routine care if approved.”

Following are eligibility criteria guidances issued prior to today:

• Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings: Guidance for Industry
• Cancer Clinical Trial Eligibility Criteria: Brain Metastases
• Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients
• Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections
• Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies

Follow the Oncology Center of Excellence on X (formerly Twitter) @FDAOncology.