title: New European Clinical Trial Regulation: perception and expectations in Italy.
abstract: BACKGROUND
  In July 2012, the European Commission formalized the proposal for a European Clinical Trial Regulation that should replace the European Clinical Trials Directive 2001/20/CE. The new Regulation 536/2014 entered into force in June 2014 and it was expected to be applied not earlier than May 2016. Indeed, at the time, all required central tools are not yet available and new forecasts indicate it will become effective at the end of 2018. The aims of the Regulation are the promotion of higher standards in patient's safety and increasing transparency in Clinical Trials, also by changing the application process.
  
  
  METHODS
  An online survey was conducted among the Italian's Clinical Research Coordinators and Clinical Investigators to examine the perception and knowledge about the upcoming changes in Clinical Trials. A total of 190 Clinical Research Coordinators and 80 Clinical Investigators were surveyed.
  
  
  RESULTS
  Clinicians are less aware of the content of the Regulation than Clinical Research Coordinators, who demonstrate an extensive expertise on the topic (84.4%), mainly reached through self-training. The majority of the Investigators (74%) believes that their site's facilities and staff already met all the requirements imposed by the Regulation while Clinical Research Coordinators are less optimistic: 65.2% of them believes that the site staff is not yet fully aware of changes associated to its implementation.
  
  
  CONCLUSIONS
  The general opinion of the interviewed is that the new Regulation will strongly affect the trial management regardless of their type and phase, and the fulfillment of the imposed requirements represents an opportunity that Italy should not miss to increase its attractiveness to the pharmaceutical market.
authors.affiliation: Medical Oncology, Candiolo Cancer Institute, Candiolo.
authors.forename: C
authors.initials: C
authors.lastname: Cagnazzo
authors.affiliation: ICON Plc, Milano.
authors.forename: S
authors.initials: S
authors.lastname: Campora
authors.affiliation: Multi-Specialists and Transplants, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano.
authors.forename: E
authors.initials: E
authors.lastname: Ferretti
authors.affiliation: Oncology Department, AUO San Luigi Gonzaga, Orbassano.
authors.forename: F
authors.initials: F
authors.lastname: Arizio
authors.affiliation: Chemotherapy Unit, Istituto Ortopedico Rizzoli, via Pupilli, 1, 40136 Bologna, Italy.|Italian Sarcoma Group, Bologna, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Marchesi
mesh_terms: D001291:Attitude of Health Personnel; D001364:Awareness; D002986:Clinical Trials as Topic / Q000592:standards*; D019983:Guideline Adherence / Q000592:standards*; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007558:Italy; D010465:Perception; D017410:Practice Guidelines as Topic / Q000592:standards*; D012108:Research Personnel / Q000523:psychology / Q000592:standards*; D011795:Surveys and Questionnaires
keywords: Clinical Investigators; Clinical Research Coordinator; Clinical Trials; European Clinical Trial Regulation; Italy; survey