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# Laboratory Value-Based Eligibility Criteria in Cancer Trials Guidance
- URL: https://www.fdaweb.com/laboratory-value-based-eligibility-criteria-in-cancer-trials-guidance/
- Published: 2026-07-27T12:00:00.000Z
- Updated: 2026-09-14T13:43:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161522

A final FDA guidance is urging sponsors of cancer clinical trials to broaden laboratory value-based eligibility criteria to reduce unnecessary barriers to patient participation while maintaining appropriate safety protections. The agency said overly restrictive laboratory requirements can limit enrollment, reduce trial diversity, and make study results less representative of the patients who will ultimately receive approved therapies.

The [guidance](https://www.fda.gov/media/178013/download?ref=fdaweb.com), “Cancer Clinical Trial Eligibility Criteria: Laboratory Values,” recommends that laboratory-based exclusion criteria be used only when scientifically justified by a drug's safety profile, mechanism of action, or expected toxicity. FDA also advises sponsors to reassess eligibility criteria as clinical data accumulate, particularly when moving from early- to late-stage trials, and to eliminate restrictions that are no longer warranted.

The agency notes that unnecessarily strict requirements for kidney, liver, and blood function have historically excluded many patients — including older adults and individuals with naturally occurring laboratory differences across racial and ethnic populations — from participating in cancer studies. FDA said broader eligibility criteria can improve the generalizability of clinical trial results and provide a more complete understanding of a drug's benefit-risk profile in real-world patients.