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Master protocols: efficient clinical trial design strategies to expedite development of oncology drugs and biologics
Master protocols: efficient clinical trial design strategies 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 Trial Protocols as Topic
Clinical Trials as Topic
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration - Genre(s):
- Technical Report
- Abstract:
- This guidance provides recommendations to sponsors of drugs or biologics for the treatment of cancer regarding the design and conduct of clinical trials intended to simultaneously evaluate more than one investigational drug and/or more than one cancer type within the same overall trial structure (master protocols) in adult and pediatric cancers. In general, the recommended phase 2 dose (RP2D) should have been established for an investigational drug or drugs evaluated in a master protocol. This guidance is intended to serve as advice and a focus for continued discussions among FDA, pharmaceutical sponsors, the academic community, and the public. This guidance describes aspects of master protocol designs and trial conduct and related considerations, such as biomarker codevelopment and statistical analysis considerations, and provides recommendations on the information that sponsors should submit to FDA and on how sponsors can interact with FDA to facilitate efficient review. This guidance does not cover first-in-human or early stage clinical trials using expansion cohorts to expedite drug development. FDA addresses that topic in the draft guidance for industry Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics (August 2018). 4 There are many aspects of study design, statistical analysis, choice of study endpoints, and development of biomarkers that are not addressed in this guidance but are considered in other FDA guidances, including the 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), which were developed by the International Conference for Harmonisation (ICH) and adopted by FDA, as well as the guidance for industry 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 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 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 (ii, 24 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 9918452088706676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918452088706676