Pharmacogenomics in early-phase clinical development.

dc.contributor.author

Burt, Tal

dc.contributor.author

Dhillon, Savita

dc.coverage.spatial

England

dc.date.accessioned

2015-01-15T14:02:42Z

dc.date.issued

2013-07

dc.description.abstract

Pharmacogenomics (PGx) offers the promise of utilizing genetic fingerprints to predict individual responses to drugs in terms of safety, efficacy and pharmacokinetics. Early-phase clinical trial PGx applications can identify human genome variations that are meaningful to study design, selection of participants, allocation of resources and clinical research ethics. Results can inform later-phase study design and pipeline developmental decisions. Nevertheless, our review of the clinicaltrials.gov database demonstrates that PGx is rarely used by drug developers. Of the total 323 trials that included PGx as an outcome, 80% have been conducted by academic institutions after initial regulatory approval. Barriers for the application of PGx are discussed. We propose a framework for the role of PGx in early-phase drug development and recommend PGx be universally considered in study design, result interpretation and hypothesis generation for later-phase studies, but PGx results from underpowered studies should not be used by themselves to terminate drug-development programs.

dc.identifier

http://www.ncbi.nlm.nih.gov/pubmed/23837482

dc.identifier.eissn

1744-8042

dc.identifier.uri

https://hdl.handle.net/10161/9359

dc.language

eng

dc.publisher

Future Medicine Ltd

dc.relation.ispartof

Pharmacogenomics

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10.2217/pgs.13.81

dc.subject

Antineoplastic Agents

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Clinical Trials as Topic

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Databases, Factual

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Dose-Response Relationship, Drug

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Genome, Human

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Genome-Wide Association Study

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Humans

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Neoplasms

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Pharmacogenetics

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Polymorphism, Single Nucleotide

dc.title

Pharmacogenomics in early-phase clinical development.

dc.type

Journal article

pubs.author-url

http://www.ncbi.nlm.nih.gov/pubmed/23837482

pubs.begin-page

1085

pubs.end-page

1097

pubs.issue

9

pubs.organisational-group

Duke

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Faculty

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Published

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14

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