Clinical studies of innovative medical devices: what level of evidence for hospital-based health technology assessment?

Aurélie Boudard , Nicolas Martelli (1) , Patrice Prognon , Judith Pineau

1 GRADES - Groupe de Recherche et d'Accueil en Droit et Economie de la Santé

Like health technology assessment (HTA) agencies, hospitals are faced with requests for innovative and costly medical devices. However, local decision makers are frequently confronted with a lack of high-quality clinical data when assessing the effectiveness of innovative medical devices. The aim of this study was to quantify the level of evidence available for innovative medical devices in the context of hospital-based HTA.

Keywords: clinical trials; evaluation; hospital-based health technology assessment; innovation; level of evidence; medical device

Domains: Santé publique et épidémiologie

Aurélie Boudard, Nicolas Martelli, Patrice Prognon, Judith Pineau. Clinical studies of innovative medical devices: what level of evidence for hospital-based health technology assessment?. Journal of Evaluation in Clinical Practice, 2013, 19 (4), pp.697-702. ⟨10.1111/jep.12024⟩. ⟨hal-03402703⟩