Defining innovations of therapeutic interventions: a position paper by the Italian Society of Hospital Pharmacists.

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.