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# Draft Guide on Brain Metastases Trial Eligibility
- URL: https://www.fdaweb.com/draft-guide-on-brain-metastases-trial-eligibility/
- Published: 2019-03-13T12:00:00.000Z
- Updated: 2026-09-15T01:12:15.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143596

*Federal Register* notice: FDA has made available a draft guidance entitled “Cancer Clinical Trial Eligibility Criteria: Brain Metastases.” The document provides recommendations on the inclusion of patients with brain metastases in cancer trials. It notes that patients with brain metastases have historically been excluded from clinical trials due to concerns of poor functional status, shortened life expectancy, or increased risk of toxicity. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-03-13/pdf/2019-04584.pdf?ref=fdaweb.com).