Studies in Support of Special Populations
5. Stratified and Personalised Medicine
Stratified medicine is the use of a medicine that is targeted at a patient sub-population (a group or a proportion of patients), instead of using one medicine to treat all patients with a particular disease. The pharmaceutical industry is using this approach more and more in the development of new medicines.
Personalised medicine, on the other hand, aims to use targeted medicines and to take into account other information about the individual in order to tailor the treatment and management of the patient to their particular situation.
As these targeted medicines are by definition likely to be used by smaller patient groups the following challenges emerge:
- new trial designs, appropriate statistical methods
- new findings from molecular research and new technologies must be translated (adapted) for use in clinical trials
- proper design and development of companion diagnostics
- new techniques to discover and validate suitable biomarkers
- new reliable ways to collect and manage large amounts of data, e.g. from biobanks.
Further information about personalised medicine will be covered in other courses.