Addressing the Challenges of the Clinical Application of Pharmacogenetic Testing

Ikediobi, ON; Shin, Jaekyu; Nussbaum, RL; Phillips, KA

doi:10.1038/clpt.2009.30

Cited by 66 publications

(43 citation statements)

References 8 publications

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“…Pharmacogenomic test information is currently included in more than 100 drug labels in the US, but in most cases there is not an explicit recommendation to utilise the test as part of standard decision making [7].…”

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confidence: 99%

Personalized Medicine: Potential, Barriers and Contemporary Issues

Sorich¹

2012

CDM

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Personalized medicine has gained significant attention over the last decade as technologies for understanding biological differences between individuals have advanced dramatically. There are many potential benefits of personalized medicine including minimizing risk of drug toxicity, increasing benefit from drugs used, contributing to the sustainability of the healthcare system and facilitating drug discovery and development programs. Unfortunately there are also many barriers such as cost, complexity, high quality evidence requirements, and the need for further education that have limited the clinical translation of pharmacogenomic tests to date. Issues that need to be clarified are also considered, such as the regulatory evidence requirements for pharmacogenomic tests and the need for multiple pathways and for pharmacogenomic marker development. These issues surrounding personalized medicine are contextualized using three contemporary examples of pharmacogenetic tests involving drug metabolising enzymes: UDP glucuronosyltransferase 1A1 and irinotecan toxicity, cytochrome P450 2C19 and clopidogrel efficacy, and cytochrome P450 2C9 and warfarin dosing.

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confidence: 99%

Personalized Medicine: Potential, Barriers and Contemporary Issues

Sorich¹

2012

CDM

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“…Aus den USA wird berichtet, dass gegenwärtig bei mehr als 200 Arzneimitteln auf pharmakogenomische Tests hingewiesen wird [23]. Von der FDA wurde bereits im Jahr 2008 eine Liste von Arzneimitteln erstellt, und inzwischen ist eine Tabelle mit über 70 Arzneimitteln verfügbar, für die eine FDA-zugelassene pharmakogenomische Information in die Arzneimittel-Fachinformation aufgenommen wurde [52].…”

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“…Von der FDA wurde bereits im Jahr 2008 eine Liste von Arzneimitteln erstellt, und inzwischen ist eine Tabelle mit über 70 Arzneimitteln verfügbar, für die eine FDA-zugelassene pharmakogenomische Information in die Arzneimittel-Fachinformation aufgenommen wurde [52]. Im Einzelfall kann diese Information Aufschluss darüber geben, ob ein genetischer Test vor Therapie erforderlich ist, empfohlen wird oder ob er eine zusätzliche Information für Patienten mit einem erhöhten Risiko darstellt [23].…”

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Pharmakogenomik:HypeoderHope?

Schwab¹,

Schaeffeler²,

Zanger³

et al. 2011

Dtsch med Wochenschr

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Pharmacogenomics follows the concept of individualized medicine via targeted and tailored therapy for each patient. This is aided by current progress in human genome research that provided the basis to link genetic markers with pathogenesis and progression for the definition of new therapy options. To achieve this it will be necessary to show the validity and clinical utility of pharmacogenomic tests prior to release. The implementation of pharmacogenomics into clinical practise is a momentous future challenge that requires the establishment of interdisciplinary networks and professional organizations.

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“…As another example, abacavir, an anti-HIV drug, results in serious side effects among patients with the HLA-B5701 allele, making prospective pharmacogenetic testing a realistic strategy for avoiding these adverse events. [8][9][10] These examples demonstrate how genetic testing facilitates tailored treatments, leading to greater effectiveness and/or fewer adverse effects. Further, genetic testing may be useful for predicting genetic risk for different diseases-i.e., as a surveillance tool.…”

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confidence: 99%

Barriers to integrating personalized medicine into clinical practice: a best–worst scaling choice experiment

Najafzadeh

Lynd

Davis

et al. 2012

Genetics in Medicine

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Purpose: As advances in genomics make genome sequencing more affordable, the availability of new genome-based diagnostic and therapeutic strategies (i.e., personalized medicine) will increase. This wave will hit front-line physicians who may be faced with a plethora of patients' expectations of integrating genomic data into clinical care. The objective of this study was to elicit the preferences of physicians regarding applying personalized medicine in their clinical practice as these strategies become available.methods: Using a best-worst scaling (BWS) choice experiment, we estimated the relative importance of attributes that influence physicians' decisions for using personalized medicine. Six attributes were included in the BWS: type of genetic tests, training for genetic testing, clinical guidelines, professional fee, privacy protection laws, and cost of genetic tests. A total of 197 physicians in British Columbia completed the experiment. Using latent class analysis (LCA), we explored the physicians' heterogeneities in preferences.Results: "Type of genetic tests" had the largest importance, suggesting that the physicians' decision was highly influenced by the availability of genetic tests for patients' predisposition to diseases and/or drug response. "Training" and "guidelines" were the attributes with the next highest importance. LCA identified two classes of physicians. Relative to class 2, class 1 had a larger weight for the "type of genetic tests, " but smaller weights for "professional fee" and "cost of tests. " conclusion:We measured relative importance of factors that affect the decision of physicians to incorporate personalized medicine in their practice. These results can be used to design the policies for supporting physicians and facilitating the use of personalized medicine in the future.Genet Med 2012:14(5):520-526

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Addressing the Challenges of the Clinical Application of Pharmacogenetic Testing

Cited by 66 publications

References 8 publications

Personalized Medicine: Potential, Barriers and Contemporary Issues

Personalized Medicine: Potential, Barriers and Contemporary Issues

Pharmakogenomik:HypeoderHope?

Barriers to integrating personalized medicine into clinical practice: a best–worst scaling choice experiment

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