title: Defining innovations of therapeutic interventions: a position paper by the Italian Society of Hospital Pharmacists.
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.
authors.affiliation: Laboratorio SIFO di Farmacoeconomia, c/o Area Vasta Centro Toscana, Regional Health System, Via Guimaraes 9-11, 59100, Prato, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Adami
authors.forename: Susanna
authors.initials: S
authors.lastname: Ciampalini
authors.forename: Marisa
authors.initials: M
authors.lastname: Dell'Aera
authors.forename: Roberta
authors.initials: R
authors.lastname: Di Turi
authors.forename: Annalisa
authors.initials: A
authors.lastname: Ferrarese
authors.forename: Andrea
authors.initials: A
authors.lastname: Messori
authors.forename: Angelo
authors.initials: A
authors.lastname: Palozzo
authors.forename: Piera
authors.initials: P
authors.lastname: Polidori
authors.forename: Marilena
authors.initials: M
authors.lastname: Romero
authors.forename: Francesca
authors.initials: F
authors.lastname: Venturini
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D004059:Diffusion of Innovation; D015507:Drugs, Investigational / Q000145:classification* / Q000592:standards / Q000627:therapeutic use*; D023381:Endpoint Determination; D019317:Evidence-Based Medicine; D006801:Humans; D007558:Italy; D017410:Practice Guidelines as Topic; D012107:Research Design / Q000592:standards; D012957:Societies, Pharmaceutical / Q000592:standards; D009626:Terminology as Topic; D016896:Treatment Outcome
chemical_list: D015507:Drugs, Investigational