Journal article
Criteria of Evidence to Move Potential Chemopreventive Agents into Late Phase Clinical Trials
Current drug targets, Vol.12(13), pp.1983-1988
01 Dec 2011
PMID: 21158704
Featured in Collection : UN Sustainable Development Goals @ Drexel
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.
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Details
- Title
- Criteria of Evidence to Move Potential Chemopreventive Agents into Late Phase Clinical Trials
- Creators
- Ronan J. Kelly - National Institutes of HealthAriel Lopez-Chavez - National Institutes of HealthEva Szabo - National Institutes of Health
- Publication Details
- Current drug targets, Vol.12(13), pp.1983-1988
- Publisher
- Bentham Science Publ Ltd
- Number of pages
- 6
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- General Internal Medicine
- Web of Science ID
- WOS:000299612100010
- Scopus ID
- 2-s2.0-82055197121
- Other Identifier
- 991022060042604721
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- Web of Science research areas
- Pharmacology & Pharmacy