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Candidate Gene Testing in Clinical Cohort Studies with Multiplexed Genotyping and Mass Spectrometry
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Published on: June 21, 2018

Pharmacogenomics in early-phase clinical development.

Tal Burt1, Savita Dhillon

  • 1Duke Global Proof-of-Concept (POC) Research Network, Duke Clinical Research Unit (DCRU) & Duke Clinical Research Institute (DCRI), Duke University, Durham, NC 27710, USA. tal.burt@duke.edu

Pharmacogenomics
|July 11, 2013
PubMed
Summary
This summary is machine-generated.

Pharmacogenomics (PGx) can personalize drug development, but is underutilized by industry. Integrating PGx early can improve trial design and decision-making, though results from small studies require caution.

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Area of Science:

  • Pharmacogenomics
  • Clinical Trial Design
  • Drug Development

Background:

  • Pharmacogenomics (PGx) utilizes genetic information to predict individual drug responses, impacting safety, efficacy, and pharmacokinetics.
  • Early-phase clinical trials can leverage PGx to refine study design, participant selection, and ethical considerations.
  • PGx insights from early trials can inform later-phase studies and pipeline decisions.

Purpose of the Study:

  • To review the current application of pharmacogenomics in early-phase drug development.
  • To identify barriers hindering the adoption of PGx by drug developers.
  • To propose a framework for integrating PGx into early drug development and recommend best practices.

Main Methods:

  • Review of the clinicaltrials.gov database for trials including pharmacogenomics (PGx) outcomes.
  • Analysis of the proportion of PGx trials conducted by academic institutions versus drug developers.
  • Discussion of identified barriers to PGx application in drug development.

Main Results:

  • Pharmacogenomics is rarely employed by drug developers in early-phase trials.
  • Of 323 trials with PGx outcomes, 80% were conducted by academic institutions post-regulatory approval.
  • Significant barriers exist for the widespread application of PGx in drug development.

Conclusions:

  • A framework is proposed for the role of PGx in early drug development.
  • PGx should be universally considered in study design, interpretation, and hypothesis generation for later-phase studies.
  • Results from underpowered PGx studies should not solely dictate the termination of drug development programs.