Phase 0 trials: Expediting the development of chemoprevention agents

Shivaani Kummar, James H. Doroshow

Research output: Contribution to journalShort surveypeer-review

11 Scopus citations

Abstract

Phase 0 trials are first-in-human clinical trials performed under the Exploratory IND [investigational new drug] Guidance of the U.S. Food and Drug Administration. Unlike traditional phase I trials, these studies have no therapeutic or diagnostic intent but instead aim to provide only pharmacokinetic and/or pharmacodynamic data to inform the next step in developing an agent. We discuss the role that such trials, including one reported by Reid and colleagues (beginning on page 347 in this issue of the journal), can play in expanding the number of drugs that are evaluated for chemoprevention while compressing the drug-development timeline.

Original languageEnglish (US)
Pages (from-to)288-292
Number of pages5
JournalCancer Prevention Research
Volume4
Issue number3
DOIs
StatePublished - Mar 2011
Externally publishedYes

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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