The US Food and Drug Administration (FDA) has finalised two guidance documents designed to help sponsors, Institutional Review Boards (IRBs) and investigators stop unnecessarily excluding cancer patients from clinical trials.
Published in the Federal Register on 28 July 2026, the guidances, Cancer Clinical Trial Eligibility Criteria: Laboratory Values and Cancer Clinical Trial Eligibility Criteria: Performance Status, close out draft versions first issued back in April 2024, and continue the FDA’s ongoing effort to make oncology trials more representative of real-world patients.
The primary concern driving both documents is eligibility criteria. This criteria is often copied from trial to trial as a form of template, rather than being rebuilt around the actual requirements for a specific study. The FDA warns that this habit can slow enrolment, cut off patient access and skew results away from real-world treatment effects.
The laboratory values guidance focuses on organ function and other lab-based thresholds, pushing sponsors to justify each cut-off rather than defaulting to conservative, historically ‘safe’ numbers that may screen out patients who could still benefit from and tolerate treatment. Changes from the 2024 draft guidance are described as minor clarifications.
The performance status guidance aims to change a longstanding practice of excluding patients with lower functional status from trials. The FDA’s finalised version adds new detail compared with the draft, demonstrating to sponsors how enrolling broader groups can affect trial retention and sample size planning.
However, neither guidance is binding: sponsors can still take alternative approaches that satisfy the underlying regulations but together, they lay out the FDA’s expectations for eligibility criteria in future oncology trials. Both documents are available now through the FDA’s guidance document search and comments remain open indefinitely through the respective docket for laboratory values and performance status. Questions can be directed to the FDA’s Oncology Center of Excellence at OCE-Guidances@fda.hhs.gov.
