> ## 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.

# 4 Cancer Clinical Trial Eligibility Criteria Guides
- URL: https://www.fdaweb.com/4-cancer-clinical-trial-eligibility-criteria-guides/
- Published: 2020-07-10T12:00:00.000Z
- Updated: 2026-09-14T16:20:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147170

FDA has released four cancer clinical trial eligibility criteria guidances. A guide on “[Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cancer-clinical-trial-eligibility-criteria-patients-hiv-hepatitis-b-virus-or-hepatitis-c-virus?ref=fdaweb.com)” provides recommendations on the inclusion of patients with human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) infections. “Eligibility criteria that address requirements regarding relevant concurrent antiviral and other therapies (e.g., antibiotic prophylaxis) and degree of immunocompetence in patients with HIV, HBV, or HCV infections should be designed in a manner that is appropriate for a given cancer, investigational drug (for instance taking into account immunosuppressive potential), and intended use population,” the document says. In cases where there is a strong rationale for exclusion, it says that such rationale should be addressed in the trial protocol.

The guide on “[Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cancer-clinical-trial-eligibility-criteria-patients-organ-dysfunction-or-prior-or-concurrent?ref=fdaweb.com)” The document says that patients with organ dysfunction are often excluded from trials. Additionally, as life-spans increase, more patients are expected to have prior or concurrent malignancies and trial recruitment may favor younger patients, which may not be fully representative of the population for whom the drug will be indicated, it says. “Designing cancer clinical trials that include patients with organ dysfunction and prior or concurrent malignancies and including this information in the labeling promotes the safe and effective use of these products across a broader patient population,” it says.

The guide on “[Cancer Clinical Trial Eligibility Criteria: Brain Metastases](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cancer-clinical-trial-eligibility-criteria-brain-metastases?ref=fdaweb.com)” encourages designing clinical trials that include such patients and including this information in the labeling. “Evidence of clinical efficacy in the subset of patients with brain metastases compared to available therapy, with similar efficacy in patients without brain metastases, could serve as the basis for one or more expedited programs (i.e., fast track designation, breakthrough therapy designation, priority review designation, and/or accelerated approval),” it says. “Labeling claims would depend on the trial design, including the sample size and analysis plan with pre-specified hypothesis, and could be included in an indication statement or clinical studies section.”

And the guide on “[Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cancer-clinical-trial-eligibility-criteria-minimum-age-considerations-inclusion-pediatric-patients?ref=fdaweb.com)” says that eligibility of a specific pediatric population for a cancer clinical trial should be considered when there is clinical evidence or a strong scientific rationale to suggest that “pediatric patients with a specific cancer diagnosis, histologic subtype, or tumor associated with the same relevant molecular target may benefit and when there is compelling nonclinical and/or adequate clinical information to sufficiently justify patient risk.” It recommends that applicants seek advice from FDA before submitting protocols that include provisions for enrolling pediatric patients, particularly those less than 12 years of age.