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Designing pharmacogenetic projects in industry: practical design perspectives from the Industry Pharmacogenomics Working Group

The Pharmacogenomics Journal volume 9, pages 14–22 (2009)Cite this article

Abstract

Pharmacogenetic association studies have the potential to identify variations in DNA sequence which impact drug response. Identifying these DNA variants can help to explain interindividual variability in drug response; this is the first step in personalizing dosing and treatment regimes to a patient's needs. There are many intricacies in the design and analysis of pharmacogenetic association studies, including having adequate power, selecting proper endpoints, detecting and correcting the effects of population stratification, modeling genetic and nongenetic covariates accurately, and validating the results. At this point there are no formal guidelines on the design and analysis of pharmacogenetic studies. The Industry Pharmacogenomics Working Group has initiated discussions regarding potential guidelines for pharmacogenetic study design and analyses (http://i-pwg.org) and the results from these discussions are presented in this paper.

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Author information

Authors and Affiliations

  1. BioStat Solutions Inc., Mount Airy, MD, USA

    C M Bromley & A Prokop

  2. Eli Lilly and Company, Indianapolis, IN, USA

    S Close, B Fijal, W Liu & C Lopez-Correa

  3. Johnson and Johnson Pharmaceutical Research and Development, Raritan, NJ, USA

    N Cohen, R Favis & D Wang

  4. Schering-Plough, Kenilworth, NJ, USA

    F Gheyas

  5. Novartis Institute of Biomedical Research, Cambridge, MA, USA

    J B Singer

  6. Orion Corporation Orion Pharma, Espoo, Finland

    A Snapir

  7. Teva Pharmaceutical Industries, Netanya, Israel

    A Tchelet & D Goldstaub

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  1. C M Bromley
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Correspondence to C M Bromley.

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None declared.

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Bromley, C., Close, S., Cohen, N. et al. Designing pharmacogenetic projects in industry: practical design perspectives from the Industry Pharmacogenomics Working Group. Pharmacogenomics J 9, 14–22 (2009). https://doi.org/10.1038/tpj.2008.11

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