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Review
. 2013 Jul;14(9):1085-97.
doi: 10.2217/pgs.13.81.

Pharmacogenomics in early-phase clinical development

Tal Burt  1 , Savita Dhillon
Affiliations
Review

Pharmacogenomics in early-phase clinical development

Tal Burt et al. Pharmacogenomics. 2013 Jul.

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.

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Figures

Figure 1
Figure 1. Total number of trials with pharmacogenomics outcomes (and percentage of total trials) per year in the clinicaltrials.gov database
Studies are divided into early phase (Phases 0, I and II) and late phase (Phases III and IV) 1999–2012. PGx: Pharmacogenomics.
Figure 2
Figure 2. The percentage of pharmacogenomics studies sponsored by industry and academia
Figure 3
Figure 3. Number of pharmacogenomics studies per therapeutic area
CVS: Cardiovascular system; GI: Gastrointestinal; PGx: Pharmacogenomics.
See this image and copyright information in PMC

References

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Website

    1. Clinicaltrials.gov database. www.clinicaltrials.gov.

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