> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Guide on Including Organ Dysfunction Patients in Trials
- URL: https://www.fdaweb.com/guide-on-including-organ-dysfunction-patients-in-trials/
- Published: 2019-03-13T12:00:00.000Z
- Updated: 2026-09-15T01:12:10.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143599

*Federal Register* notice: FDA has made available a draft guidance entitled “Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies.” The document provides recommendations about the inclusion of patients with organ dysfunction or with prior or concurrent malignancies, which FDA says can maximize the generalizability of trial results and the ability to understand a therapy’s benefit-risk profile across the patient population likely to use the drug in clinical practice. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-03-13/pdf/2019-04573.pdf?ref=fdaweb.com).