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Expansion cohorts: use in first-in-human clinical trials to expedite development of oncology drugs and biologics
Expansion cohorts: use in first-in-human clinical trials to expedite development of oncology drugs and biologics
- 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 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, March 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Antineoplastic Agents
Biological Products
Clinical Trials as Topic
Drug Development -- legislation & jurisprudence
Drug Development -- standards
Medical Oncology
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration - Genre(s):
- Technical Report
- Abstract:
- The purpose of this guidance is to provide advice to sponsors regarding the design and conduct of first-in-human (FIH) clinical trials intended to efficiently expedite the clinical development of oncology drugs, including biological products, through multiple expansion cohort trial designs.2 These are trial designs that employ multiple, concurrently accruing subject cohorts, where individual cohorts assess different aspects of the safety, pharmacokinetics, and antitumor activity of the drug product. This guidance provides FDA’s current thinking regarding (1) characteristics of drug products best suited for consideration for development under a multiple expansion cohort trial; (2) information to include in investigational new drug applications (INDs) to support the use of individual cohorts; (3) when to interact with FDA on planning and conduct of multiple expansion cohort trials; and (4) safeguards to protect subjects enrolled in FIH expansion cohort trials. This guidance does not address all issues relating to clinical trial design, statistical analysis, or the biomarker development process. Those topics are addressed in other guidances including the International Council for Harmonisation (ICH) guidances for industry E9 Statistical Principles for Clinical Trials (September 1998) and E10 Choice of Control Group and Related Issues in Clinical Trials (May 2001) as well as the guidance for industry and FDA staff In Vitro Companion Diagnostic Devices (August 2014). 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’s guidance documents should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances 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 (16 pages)).
- NLM Unique ID:
- 9918451888806676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918451888806676