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

作者：Adami Silvia; Ciampalini Susanna; Dell'Aera Marisa; Di Turi Roberta; Ferrarese Annalisa; Messori Andrea^*; Palozzo Angelo; Polidori Piera; Romero Marilena; Venturini Francesca

来源：International Journal of Clinical Pharmacy, 2012, 34(2): 259-262.

DOI：10.1007/s11096-012-9618-2

• Innovation
• Italy
• Medicines
• Medical devices
• SIFO
• Study end-points
• Study evaluation

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.

• 出版日期2012-4