Abstract
Defining innovation in pharmacotherapy is complex because general definitions cannot be easily adapted to the specificity of different therapeutic areas. The Italian Society of Hospital Pharmacists has developed a position paper in which three criteria are used to recognise innovation to a new intervention: (1) clinical relevance of the trial's primary end-point; (2) evidence of superiority; (3) use of an adequate comparator in the controlled trial. Clinically relevant end-points should appear in predetermined lists by therapeutic area managed by our society; likewise, the third criterion must be documented by an authoritative therapeutic guideline recognised to be still valid. A preliminary attempt is presented to retrospectively apply these criteria, particularly the first one, to a series of 21 clinical trials; this initial experience has generated a first list of clinically relevant end-points. This approach of innovation assessment is proposed for application also in the field of medical devices.
Original language | English |
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Pages (from-to) | 259-262 |
Number of pages | 4 |
Journal | International Journal of Clinical Pharmacy |
Volume | 34 |
Issue number | 2 |
DOIs | |
Publication status | Published - Apr 2012 |
Keywords
- Innovation
- Italy
- Medical devices
- Medicines
- SIFO
- Study end-points
- Study evaluation
ASJC Scopus subject areas
- Pharmacology (medical)
- Pharmaceutical Science
- Pharmacology
- Toxicology
- Pharmacy