PhRMA survey of pharmacogenomic and pharmacodynamic evaluations: what next?

Clin Pharmacol Ther. 2012 Jun;91(6):1035-43. doi: 10.1038/clpt.2011.334.

Abstract

Interindividual variation in pharmacodynamic (PD) response to drugs is an ongoing area of research for drugs in clinical development, pre- and postapproval. To characterize how pharmacogenomic (PG ) variations can serves a predictor of differences in PD outcomes, the pharmaceutical industry has incorporated PG /PD analysis into clinical drug development. The Pharmaceutical Research and Manufacturers of America (PhRMA ) and the Industry Pharmacogenomics Working Group (I-PWG) conducted a survey of 16 pharmaceutical companies to ascertain to what extent PG/PD research is being incorporated into drug development. The survey results showed that, while the industry has made some attempt to incorporate PG/PD studies into drug development, application has been inconsistent. Nevertheless, several valid PG/PD markers have since emerged in drug labels. The I-PWG considers PG/PD research an important approach to improving success rates in drug development. This article reports the results of the survey and proposes steps toward increasing the use of PG/PD research by the industry.

MeSH terms

  • Clinical Trials as Topic
  • DNA / genetics
  • Data Collection
  • Data Interpretation, Statistical
  • Drug Industry
  • Europe
  • Internet
  • Laboratories / standards
  • Legislation, Drug
  • Pharmacogenetics / trends*
  • Pharmacology / trends*
  • Precision Medicine
  • Quality Control
  • Specimen Handling / standards
  • Surveys and Questionnaires
  • United States

Substances

  • DNA