Criteria of evidence to move potential chemopreventive agents into late phase clinical trials

Ronan J. Kelly, Ariel Lopez-Chavez, Eva Szabo

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1983-1988
Number of pages6
JournalCurrent Drug Targets
Volume12
Issue number13
DOIs
StatePublished - Dec 2011
Externally publishedYes

Fingerprint

Decision Making
Decision making
Clinical Trials
Phase III Clinical Trials
Demonstrations
Safety
Neoplasms

Keywords

  • Cancer
  • Chemoprevention
  • Clinical trials

ASJC Scopus subject areas

  • Drug Discovery
  • Pharmacology
  • Clinical Biochemistry
  • Molecular Medicine

Cite this

Criteria of evidence to move potential chemopreventive agents into late phase clinical trials. / Kelly, Ronan J.; Lopez-Chavez, Ariel; Szabo, Eva.

In: Current Drug Targets, Vol. 12, No. 13, 12.2011, p. 1983-1988.

Research output: Contribution to journalArticle

Kelly, Ronan J. ; Lopez-Chavez, Ariel ; Szabo, Eva. / Criteria of evidence to move potential chemopreventive agents into late phase clinical trials. In: Current Drug Targets. 2011 ; Vol. 12, No. 13. pp. 1983-1988.
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