Cancer clinical trial eligibility criteria: patients with HIV, hepatitis B Virus, or hepatitis C Virus Infections

Cancer clinical trial eligibility criteria: patients with HIV, hepatitis B Virus, or hepatitis C Virus Infections

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
United States. Food and Drug Administration. Office of Medical Products and Tobacco. Oncology Center of Excellence, issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Publication:
[Silver Spring, MD] : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Language(s):
English
Format:
Text
Subject(s):
Clinical Trials as Topic
Hepatitis B
Hepatitis C
HIV
Neoplasms
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of drugs or biological products regulated by CDER and CBER for the treatment of cancer. Specifically, this guidance includes recommendations regarding the inclusion of patients with human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) infections. This guidance is intended to assist stakeholders, including sponsors and institutional review boards, responsible for the development and oversight of clinical trials.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (8 pages)).
NLM Unique ID:
9918227352206676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918227352206676