Priority Medicines for Europe and the World 2013 Update. Background Paper 7 - Cross-cutting Themes. BP 7.4 - Pharmacogenetics and Stratified Medicine
(2013; 38 pages)


Stratified or personalised medicine is a rapidly developing field that will have major impact on healthcare in the coming decades. Without applying the concept of stratified medicine, a particular treatment is targeted to the whole patient group, without being able to predict the treatment response in patients. Stratified medicine allows medicines to be targeted to those patients who (best) respond to therapy and/or to be avoided in patients who are most likely to experience side effects. Thus, stratified medicine shows great promise in the improved and safer usage of existing medicines in high, as well as low, resource settings- In addition, it demonstrates potential for the identification of new drug targets and the development of new diagnostic tools. The term "stratified medicine", however, might be more accurate than the term "personalised medicine" in encompassing the potential and hopes of the new -omics era for medicine and public health, in which the main focus will be in the stratification of patient populations on the basis of biomarkers (e.g. genetic variations and protein expression). Scientific technologies in the field of genomics and biomarker discovery are advancing at a rapid pace, shifting from single to complex multifactorial diseases and from monogenic (assessing one single gene) to polygenic (assessing multiple genes at the same time) approaches. Despite the rapid scientific advances, the implementation of stratified medicine in health care systems remains low. This is due in part to (current) scientific limitations, and the lack of standardization for response outcomes (i.e. adverse drug reactions which complicate the comparability of studies), which complicates the comparability of studies. Furthermore, successful replication is generally low, and a global or European pharmacogenomic database with a thorough inventory of available knowledge and biological specimens is lacking. Moreover, societal and regulatory limitations hinder implementation; there is a need for a well-organised technology infrastructure, professional training in the use and interpretation of testing, as well as internationally aligned ethical, legal and regulatory frameworks. A summary of research and policy priorities for stratified medicine is given. The clinical implementation of stratified medicine also requires basic, translational, as well as regulatory studies.

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