Pharmacogenomics in early-phase clinical development.
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.
Type
Journal articleSubject
Antineoplastic AgentsClinical Trials as Topic
Databases, Factual
Dose-Response Relationship, Drug
Genome, Human
Genome-Wide Association Study
Humans
Neoplasms
Pharmacogenetics
Polymorphism, Single Nucleotide
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https://hdl.handle.net/10161/9359Published Version (Please cite this version)
10.2217/pgs.13.81Publication Info
Burt, Tal; & Dhillon, Savita (2013). Pharmacogenomics in early-phase clinical development. Pharmacogenomics, 14(9). pp. 1085-1097. 10.2217/pgs.13.81. Retrieved from https://hdl.handle.net/10161/9359.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
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Show full item recordScholars@Duke
Tal Burt
Assistant Professor of Psychiatry and Behavioral Sciences
Tal Burt, MD is a Board-Certified psychiatrist and clinical researcher trained in
Israel, Italy, France, and the United States. After joining the faculty at the Department
of Psychiatry at Columbia University, Dr. Burt joined Pfizer Inc., and then Eisai
Pharmaceuticals, as Senior Medical Director with responsibilities in all phases of
clinical research and development. He then joined Duke and was the founding director
of the Investigational Medicine Unit (IMU) in Singapore and th
This author no longer has a Scholars@Duke profile, so the information shown here reflects
their Duke status at the time this item was deposited.

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