07/28/2026
FDA's Final Guidance to Expand Participation in Cancer Clinical Trials
The FDA’s Oncology Center of Excellence is announcing three final guidance documents intended to broaden eligibility criteria for participation in clinical trials of oncology drugs.
Fewer than 5% of cancer patients currently receiving treatment are enrolled in clinical trials even though more than 70% say they are willing to participate. The guidance documents address one reason for low participation – stringent and complex clinical trial eligibility criteria.
“Unnecessarily restrictive eligibility criteria may slow subject 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,” the three guidances say in their preambles.
Each document focuses on a specific area where rigid eligibility criteria limit participation including:
- Defining who is too sick to participate. The final guidance Cancer Clinical Trial Eligibility Criteria: Performance Status Guidance for Industry, IRBs, and Clinical Investigators raises questions about the use of the common yardstick known as “performance status,” a measure of how well a patient is able to perform ordinary tasks and carry out activities of daily living. Some patients may have a low performance status because cancer has made them sick, but this status could improve once the patient is enrolled in the trial, the guidance says.
- Deciding when patients should be excluded if they are taking other medications. The final guidance Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications Guidance for Industry, IRBs, and Clinical Investigators encourages sponsors to consider whether time based “washout periods” are necessary between stopping one cancer drug and beginning the experimental drug and also makes some allowances for patients taking other medications.
- Determining the appropriate laboratory value for test results that determine trial eligibility. The final guidance Cancer Clinical Trial Eligibility Criteria: Laboratory Values Guidance for Industry, IRBs, and Clinical Investigators discusses taking a more scientific and safety-focused approach to tests commonly used to determine whether a patient might qualify to participate in a clinical trial.
The three guidance documents advance one of the goals of HHS’ Operation Trialblazer Initiative, a coordinated federal initiative designed to accelerate drug development and reclaim America’s edge in clinical research. The Trialblazer Roadmap, released in late June, tasked the FDA with Improving patient and participant access and engagement in clinical trials.
The documents are part of a series of guidances developed as a result of workshops with Friends of Cancer Research and the American Society of Clinical Oncology.