An evaluation of regulatory and commercial barriers to stratified medicine development and adoption

Pharmacogenomics J. 2015 Feb;15(1):6-12. doi: 10.1038/tpj.2014.51. Epub 2014 Oct 7.


Today, a range of products based on genomics, proteomics and metabolomics have facilitated the development of 'stratified' medicines and companion diagnostics. This investigation profiles a series of targeted medicines and corresponding diagnostics, and their role(s) in supporting evidence-based medicine. Despite their potential benefits we found that scientific, financial and regulatory barriers impede the development and adoption of companion diagnostics. Therefore, in order to realise improvements to the risk/benefit profiles of health-care interventions-notably reducing clinical uncertainty-conferred by the use of companion diagnostics, industry representatives, health-care providers and regulators will need a coordinated response to overcome these barriers.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Clinical Trials, Phase III as Topic / legislation & jurisprudence
  • Clinical Trials, Phase III as Topic / standards
  • Drug Discovery / legislation & jurisprudence*
  • Drug Discovery / standards*
  • Drug Industry / legislation & jurisprudence*
  • Drug Industry / standards*
  • Humans
  • Precision Medicine / standards