Defining innovations of therapeutic interventions: a position paper by the Italian Society of Hospital Pharmacists
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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.
KeywordsInnovation Italy Medicines Medical devices SIFO Study end-points Study evaluation
We thank the Laboratorio di Farmacoeconomia (Sabrina Trippoli, Fabiola Del Santo, Valeria Fadda, and Dario Maratea; Firenze, Italy) of SIFO for their contribution to the development of this document.
Conflicts of interest
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