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Review
. 2009 Dec;18(12):3143-95.
doi: 10.1158/1055-9965.EPI-09-0654.

Clinical trials methods for evaluation of potential reduced exposure products

Dorothy K Hatsukami  1 , Karen Hanson, Anna Briggs, Mark Parascandola, Jeanine M Genkinger, Richard O'Connor, Peter G Shields
Affiliations
Review

Clinical trials methods for evaluation of potential reduced exposure products

Dorothy K Hatsukami et al. Cancer Epidemiol Biomarkers Prev. 2009 Dec.

Abstract

Potential reduced exposure products (PREPs) to tobacco toxicants may have promise in reducing tobacco-related morbidity or mortality or may promote greater harm to individuals or the population. Critical to determining the risks or benefits from these products are valid human clinical trial PREP assessment methods. Such an assessment involves determining the effects of these products on biomarkers of exposure and effect, which serve as proxies for harm, and assessing the potential for consumer uptake and abuse of the product. This article identifies critical methodologic issues associated with PREP assessments, reviews the methods that have been used to assess PREPs, and describes the strengths and limitations of these methods. Additionally, recommendations are provided for clinical trial PREP assessment methods and future research directions in this area based on this review and on the deliberations from a National Cancer Institute sponsored Clinical Trials PREP Methods Workshop.

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Figures

Figure 1
Figure 1
Three step model for PREP evaluation and marketing with assessment occurring by an independent scientific panel or regulatory agency after each step
Figure 2
Figure 2
Distinct components for the assessment of potential reduced exposure products
Figure 3
Figure 3
Venous blood concentrations of nicotine over time for various nicotine delivery systems
See this image and copyright information in PMC

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