Current Drug Targets

Francis J. Castellino
Kleiderer-Pezold Professor of Biochemistry
Director, W.M. Keck Center for Transgene Research
Dean Emeritus, College of Science
230 Raclin-Carmichael Hall, University of Notre Dame
Notre Dame, IN 46556


Criteria of Evidence to Move Potential Chemopreventive Agents into Late Phase Clinical Trials

Author(s): Ronan J. Kelly, Ariel Lopez-Chavez and Eva Szabo

Affiliation: LUACRG, DCP, NCI, 6130 Executive Blvd., Rm 2132, Bethesda, MD 20892, USA.


Preclinical models and data from clinical trials suggest that cancer is a preventable disease. However, demonstration of a preventive effect requires large phase III clinical trials of long duration and involves many thousands of participants. The decision to proceed with phase III studies therefore must be informed by robust efficacy and safety data. This requires a systematic review of all available preclinical, epidemiological, and clinical data, along with a mechanistic understanding of the biology of the disease under study. In this review we identify the issues that are critical to decision-making prior to embarking on late phase prevention clinical trials and provide a framework for making such decisions.

Keywords: cancer, chemoprevention, clinical trials, carcinogenesis, efficacy, EGFR, safety, oncologic, phase III trials, NSAID

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Article Details

Page: [1983 - 1988]
Pages: 6
DOI: 10.2174/138945011798184173