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International Journal of Clinical Pharmacy

, Volume 34, Issue 2, pp 259–262 | Cite as

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

  • Silvia Adami
  • Susanna Ciampalini
  • Marisa Dell’Aera
  • Roberta Di Turi
  • Annalisa Ferrarese
  • Andrea MessoriEmail author
  • Angelo Palozzo
  • Piera Polidori
  • Marilena Romero
  • Francesca Venturini
Commentary

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.

Keywords

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

Notes

Acknowledgments

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.

Funding

None.

Conflicts of interest

None.

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Copyright information

© Springer Science+Business Media B.V. 2012

Authors and Affiliations

  • Silvia Adami
    • 1
  • Susanna Ciampalini
    • 1
  • Marisa Dell’Aera
    • 1
  • Roberta Di Turi
    • 1
  • Annalisa Ferrarese
    • 1
  • Andrea Messori
    • 1
    Email author
  • Angelo Palozzo
    • 1
  • Piera Polidori
    • 1
  • Marilena Romero
    • 1
  • Francesca Venturini
    • 1
  1. 1.Laboratorio SIFO di Farmacoeconomia, c/o Area Vasta Centro ToscanaRegional Health SystemPratoItaly

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