5 Cancer Trial Eligibility Guidances

FDA has issued five new guidances intended to encourage a broadening of eligibility criteria to allow more people participating in clinical trials of drugs and biological products for treating cancer, including patients with HIV, HBV, HCV, organ dysfunction, and prior or concurrent malignancies and brain metastases. The agency says that broadening the eligibility criteria will allow for trial results that better represent the patient population that will use the drug or biological product. The guidances, four of which have the same background explanation, are: 

•          Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C virus Infections. The draft document says that because there is variability in investigational drugs and trial objectives, eligibility criteria should be developed taking into consideration the drug’s mechanism of action, the targeted disease or patient population, the drug’s anticipated safety, and the ability to recruit trial participants from the patient population to meet the trial’s objectives. “However,” it says, “some eligibility criteria have become commonly accepted over time or used as a template across trials without clear scientific or clinical rationale. Unnecessarily restrictive eligibility criteria may slow patient accrual, limit patients’ access to clinical trials, and lead to trial results that do not fully represent treatment effects in the patient population that will ultimately use the drug. Broadening the cancer trial eligibility criteria can maximize the generalizability of trial results and the ability to understand the therapy’s benefit-risk profile across the patient population likely to use the drug in clinical practice without jeopardizing patient safety.”
•        Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients.
•        Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies.
•        Cancer Clinical Trial Eligibility Criteria: Brain Metastases.
•        Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials. The document says FDA recommends inclusion of adolescent patients in disease- and target-appropriate adult oncology clinical trials to enable earlier access to investigational and approved drugs for adolescent patients with cancer. Topics included are appropriate criteria for including adolescent patients in adult oncology clinical trials at various stages of drug development, dosing and pharmacokinetic and pharmacodynamic evaluations, safety monitoring, and ethical considerations.