Cancer clinical trial eligibility criteria: available therapy in non-curative settings

Cancer clinical trial eligibility criteria: available therapy in non-curative settings

Collection:
Health Policy and Services Research
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 Drug Evaluation and Research (U.S.), issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, July 2022
Language(s):
English
Format:
Text
Subject(s):
Clinical Trials as Topic
Government Regulation
Neoplasms -- drug therapy
United States
United States. Food and Drug Administration
Genre(s):
Guideline
Technical Report
Abstract:
This guidance provides recommendations to clinical investigators and sponsors regarding the inclusion of patients who have not received available therapy2 (commonly referred to as existing treatment options) for their cancer in clinical trials of drugs3 and biological products for the treatment of cancer in the non-curative setting (i.e., when there is no potential for cure or prolonged/near normal survival). For the purpose of this guidance, non-curative is generally defined as 1) unresectable, locally advanced, or metastatic disease in solid tumors or 2) hematologic malignancies with unfavorable long-term overall survival. The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (3 pages))
NLM Unique ID:
9918486678606676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918486678606676