FDA issues guidances to broaden criteria for cancer trial eligibility

The US Food and Drug Administration (FDA) has published four draft guidances to expand eligibility criteria for cancer clinical trials and one final guidance on including adolescent patients in adult oncology trials.

The move is intended to address the eligibility criteria that have been accepted over time without a clear scientific or clinical rationale.

FDA Commissioner Scott Gottlieb said: “Overly restrictive eligibility criteria may slow patient accrual, limit patients’ access to clinical trials and lead to trial results that don’t fully represent treatment effects in the patient population that will ultimately receive the drug.”

The four draft guidances outline recommendations on the criteria for including paediatric patients, and those with human immunodeficiency virus (HIV), hepatitis B or hepatitis C viruses Infections, brain metastases, prior or existing malignancies or organ dysfunction.

These guidances were developed in collaboration with stakeholders, including the American Society of Clinical Oncology and Friends of Cancer Research.

The regulatory agency expects that the broadened criteria could maximise the trial results generalizability and understanding of the benefit-risk profile across the patient population that is likely to receive the drug in clinical practice.

Gottlieb added: “For far too long, certain patients have been unnecessarily excluded from the chance to be a part of a clinical trial.

“Today’s policies will help to shift the design of oncology clinical trials to be more representative of the patients that may ultimately benefit from novel treatments.”