title: [A programme to support clinical evaluation of medical devices: pilot experiment in the Rhône-Alpes region].
abstract: BACKGROUND
  The drug and medical devices Committee of the University Hospital of Lyon faces the weakness of clinical data available to justify medical devices purchase. The Hospital of Lyon has worked with several organisms of the Rhône-Alpes region to set up a pilot programme aimed at encouraging small and medium enterprises (SMEs) to realise clinical studies for the evaluation of their medical device. We report the results of this experiment which took place from 2007 to 2010.
  
  
  METHODS
  Eligible projects were selected on the basis of their scientific interest. A specific structure for regulatory and methodological support was set up.
  
  
  RESULTS
  Twenty companies applied, seventeen were selected. Eight research protocols were written; four clinical studies were implemented. These studies were performed by micro-companies for medical devices that could be considered as innovative device or substantial novelty. Two draft protocols were started but deferred by choice of the company. For projects that did not lead to a research protocol or study, the main causes were: a longer than expected development phase (n = 3); a problem linked to methodological feasibility (n = 1); the unsuccessful search for a principal investigator (n = 2); or the company's choice (n = 5).
  
  
  CONCLUSIONS
  This pilot experience in France has supported and trained regional SMEs in clinical research. Its continuation could encourage manufacturers to conduct clinical trials of good quality.
authors.affiliation: Unité de recherche clinique, pôle information médicale évaluation recherche, hospices civils de Lyon, 69003 Lyon, France. laure.huot@chu-lyon.fr
authors.forename: L
authors.initials: L
authors.lastname: Huot
authors.forename: E
authors.initials: E
authors.lastname: Decullier
authors.forename: G
authors.initials: G
authors.lastname: Aulagner
authors.forename: F R
authors.initials: FR
authors.lastname: Chapuis
mesh_terms: D035843:Biomedical Research; D004864:Equipment and Supplies / Q000592:standards*; D005069:Evaluation Studies as Topic; D005240:Feasibility Studies; D005602:France; D019981:Health Care Sector; D006785:Hospitals, University; D006801:Humans; D010865:Pilot Projects