The FDA’s Oncology Center of Excellence (OCE) in cooperation with CDER and CBER has released several new guidances intended to broaden the eligibility criteria for cancer clinical trials. A trial’s eligibility criteria define the patient population studied in the trial, and some patients with conditions covered by the guidances (HIV, HBV, HCV, organ dysfunction, prior or concurrent malignancies and brain metastases) have previously been excluded from cancer trials due to their conditions. Additionally, pediatric patients are also commonly excluded from adult oncology trials, which limits the usage of a new therapeutic where there may be a critical need.

There are 4 draft guidances:

1. Cancer Clinical Trial Eligibility Criteria: Patients with Human Immunodeficiency Virus, Hepatitis B Virus, or Hepatitis C Virus Infections; 
2. Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients; 
3. Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies; 
4. Cancer Clinical Trial Eligibility Criteria: Brain Metastases; 

and one final guidance:

• Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials.

Each guidance gives specific criteria currently accepted in clinical practice for inclusion of patients with lower risk and exclusion of patients with higher risk, along with rationale for the criteria.  The final guidance addresses inclusion of patients from 12-17 years of age in adult oncology trials. These guidances should assist sponsors and investigators in conducting trials that will better represent the final patient population.

September 2021 Update – the draft guidance were released as final in July 2021. The links will take you to the latest version.

Text Copyright © 2019 Katrina Rogers