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A critical analysis of barriers to the clinical implementation of pharmacogenomics.

McKinnon RA, Ward MB, Sorich MJ - Ther Clin Risk Manag (2007)

Bottom Line: It is clear that an increasingly complex series of barriers must be overcome if we are to successfully harness genomic advances in the clinical setting.Potential barriers may include cost-effectiveness of the test, ethical concerns over the use of DNA, and required educational and equipment infrastructure.Although long overdue, many of these potential barriers are now being subjected to closer examination and as a result, a framework for successful clinical uptake of pharmacogenomics is emerging.

View Article: PubMed Central - PubMed

Affiliation: Sansom Institute, School of Pharmacy and Medical Sciences, University of South Australia Adelaide, SA, Australia.

ABSTRACT
Over recent decades, basic research has yielded a large volume of data on many potentially clinically relevant genetic determinants of drug efficacy and toxicity. Until recently, most examples involved genes encoding drug-metabolizing enzymes, particularly the cytochromes P450. More recently, rapid advances in genomic technologies have enabled broader, genome-wide searches for determinants of drug response. In parallel with these pharmacogenetic studies, a new drug discovery platform, termed pharmacogenomics, has emerged which utilises genetic information to guide the selection of new drugs most likely to survive increasingly demanding safety and efficacy assessments. Together, these advances are widely promoted as the basis of a new era of drug-based therapeutics tailored to the individual. The extent to which individualized or personalized medicine will emerge as a sustainable new therapeutic paradigm is, however, the topic of much debate. It is clear that an increasingly complex series of barriers must be overcome if we are to successfully harness genomic advances in the clinical setting. Potential barriers may include cost-effectiveness of the test, ethical concerns over the use of DNA, and required educational and equipment infrastructure. Although long overdue, many of these potential barriers are now being subjected to closer examination and as a result, a framework for successful clinical uptake of pharmacogenomics is emerging.

No MeSH data available.


Related in: MedlinePlus

Idealized flow chart of the processes undertaken to bring pharmacogenomic testing from concept to clinical use.
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fig1: Idealized flow chart of the processes undertaken to bring pharmacogenomic testing from concept to clinical use.

Mentions: Unraveling the complexities of the factors influencing the eventual clinical implementation of pharmacogenomics may be best handled by following the general development pathway of pharmacogenomic tests from initial conception to broad clinical use (Figure 1). At each stage on this pathway, there are factors that directly and indirectly influence the clinical implementation of pharmacogenomics. The flow of topics covered in this review will generally mirror the flow of Figure 1. Hence we will initially focus on potential barriers encountered early in the development of a pharmacogenomic test, and progressively lead into barriers faced during the attempt to clinically utilize the pharmacogenomic protocol.


A critical analysis of barriers to the clinical implementation of pharmacogenomics.

McKinnon RA, Ward MB, Sorich MJ - Ther Clin Risk Manag (2007)

Idealized flow chart of the processes undertaken to bring pharmacogenomic testing from concept to clinical use.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2376080&req=5

fig1: Idealized flow chart of the processes undertaken to bring pharmacogenomic testing from concept to clinical use.
Mentions: Unraveling the complexities of the factors influencing the eventual clinical implementation of pharmacogenomics may be best handled by following the general development pathway of pharmacogenomic tests from initial conception to broad clinical use (Figure 1). At each stage on this pathway, there are factors that directly and indirectly influence the clinical implementation of pharmacogenomics. The flow of topics covered in this review will generally mirror the flow of Figure 1. Hence we will initially focus on potential barriers encountered early in the development of a pharmacogenomic test, and progressively lead into barriers faced during the attempt to clinically utilize the pharmacogenomic protocol.

Bottom Line: It is clear that an increasingly complex series of barriers must be overcome if we are to successfully harness genomic advances in the clinical setting.Potential barriers may include cost-effectiveness of the test, ethical concerns over the use of DNA, and required educational and equipment infrastructure.Although long overdue, many of these potential barriers are now being subjected to closer examination and as a result, a framework for successful clinical uptake of pharmacogenomics is emerging.

View Article: PubMed Central - PubMed

Affiliation: Sansom Institute, School of Pharmacy and Medical Sciences, University of South Australia Adelaide, SA, Australia.

ABSTRACT
Over recent decades, basic research has yielded a large volume of data on many potentially clinically relevant genetic determinants of drug efficacy and toxicity. Until recently, most examples involved genes encoding drug-metabolizing enzymes, particularly the cytochromes P450. More recently, rapid advances in genomic technologies have enabled broader, genome-wide searches for determinants of drug response. In parallel with these pharmacogenetic studies, a new drug discovery platform, termed pharmacogenomics, has emerged which utilises genetic information to guide the selection of new drugs most likely to survive increasingly demanding safety and efficacy assessments. Together, these advances are widely promoted as the basis of a new era of drug-based therapeutics tailored to the individual. The extent to which individualized or personalized medicine will emerge as a sustainable new therapeutic paradigm is, however, the topic of much debate. It is clear that an increasingly complex series of barriers must be overcome if we are to successfully harness genomic advances in the clinical setting. Potential barriers may include cost-effectiveness of the test, ethical concerns over the use of DNA, and required educational and equipment infrastructure. Although long overdue, many of these potential barriers are now being subjected to closer examination and as a result, a framework for successful clinical uptake of pharmacogenomics is emerging.

No MeSH data available.


Related in: MedlinePlus