The Next Phase of Chemoprevention Research

Phase 0 clinical trials are meant to explore mechanism of action, pharmacokinetics, pharmacodynamics, or biodistribution of investigational compounds in an efficient manner with relatively few subjects. Phase 0 designs have been applied sparingly in cancer research, but this issue of the journal pro...

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Bibliographic Details
Published inCancer prevention research (Philadelphia, Pa.) Vol. 4; no. 3; pp. 293 - 295
Main Authors Cohen, Ezra E.W., Schilsky, Richard L.
Format Journal Article
LanguageEnglish
Published United States 01.03.2011
Subjects
Anticarcinogenic Agents - therapeutic use
Carbazoles - pharmacology
Chemoprevention
Clinical Trials as Topic
Drug Approval - methods
Drug Screening Assays, Antitumor - methods
Humans
Medical Oncology - trends
Neoplasms - prevention & control
Research Design
United States
United States Food and Drug Administration
United States
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Summary:Phase 0 clinical trials are meant to explore mechanism of action, pharmacokinetics, pharmacodynamics, or biodistribution of investigational compounds in an efficient manner with relatively few subjects. Phase 0 designs have been applied sparingly in cancer research, but this issue of the journal provides an example of their utility reported by Reid and colleagues (beginning on page 347). Indeed, aspects of the phase 0 design lend themselves well to chemoprevention research, suggesting that this approach will become more common in the near future. Cancer Prev Res; 4(3); 293–5. ©2011 AACR.
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ISSN:1940-6207
1940-6215
1940-6215
DOI:10.1158/1940-6207.CAPR-11-0012