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GUIDANCE DOCUMENT

Cancer Clinical Trial Eligibility Criteria: Brain Metastases March 2019

Draft

Not for implementation. Contains non-binding recommendations.

Cancer Clinical Trial Eligibility Criteria: Brain Metastases

Docket Number:
FDA-2019-D-0357
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Cancer Clinical Trial Eligibility Criteria: Brain Metastases.” This draft guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of drugs or biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for the treatment of cancer. Specifically, this draft guidance includes recommendations on the inclusion of patients with brain metastases. 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. Given the prevalence of brain metastases in patients with cancer, their systematic exclusion from clinical trials may result in the assessment of an investigational drug's efficacy or safety in a trial population that is not fully representative of the patient population that will be prescribed the drug in clinical practice. Broadening cancer trial eligibility criteria can maximize the generalizability of trial results and the ability to understand the therapy's benefit-risk profile across the patient population likely to use the drug in clinical practice without jeopardizing patient safety.


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If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-0357.