title: Time spent for activation of non-profit studies in oncology in Italy.
abstract: OBJECTIVE
  The aim of this paper is to describe the time spent to activate oncological non-profit clinical trials promoted in Italy by the National Cancer Institute of Naples, following the implementation of recent European laws.
  
  
  METHODS
  Data about the process of activation of 5 non-profit multicentre clinical trials were prospectively collected through a web-based system. The impact of European guidelines was assessed by comparing the efficiency of the process between applications started before and after the decree introducing in Italy the Clinical Trial Application form (MD-CTA). Outcomes of the descriptive analyses were the time to EC opinion, the time to administrative agreement signature after a positive EC opinion, and the cumulative percentage of submissions that came to closure (either positive or negative) within four subsequent time cohorts.
  
  
  RESULTS
  From March 2007 to October 2009, 202 applications were submitted to 107 centres. Forty-four (59%) applications of those submitted before were successful, compared to 71 (55%) of those submitted after MD-CTA. Most of the failures were due to missing EC response (27% and 22%) or administrative reasons (10% and 16%, before and after, respectively); very few (4% and 7%) were due to EC refusal. The impact of the MD-CTA on time to EC opinion looked positive (median 4.1 vs 2.4 months, before and after, respectively) but a subgroup analysis revealed that the impact was limited to a comparison biased by the selection of EC. After a positive EC opinion, there was no difference before and after MD-CTA in the time to administrative agreement signature (median 3.6 and 3.8 months, respectively). A trend to shortening time to closure of the whole submission process over the time was evident, with 58% of the applications coming to closure within 6 months from submission in the most recent cohort.
  
  
  CONCLUSIONS
  In our experience there is reassuring evidence of a trend toward shortening the time spent to activate non-profit clinical trials in Italy, but the whole process still remains inefficient. Efforts should be made to improve the process, also focusing on administrative procedures.
authors.affiliation: National Cancer Institute, Naples, Italy.
authors.forename: Gianfranco
authors.initials: G
authors.lastname: De Feo
authors.forename: Simona
authors.initials: S
authors.lastname: Signoriello
authors.forename: Jane C
authors.initials: JC
authors.lastname: Bryce
authors.forename: Antonia
authors.initials: A
authors.lastname: Del Giudice
authors.forename: Giuliana
authors.initials: G
authors.lastname: Canzanella
authors.forename: Federika
authors.initials: F
authors.lastname: Crudele
authors.forename: Fiorella
authors.initials: F
authors.lastname: Romano
authors.forename: Giovanni
authors.initials: G
authors.lastname: de Matteis
authors.forename: Manuela
authors.initials: M
authors.lastname: Florio
authors.forename: Fabiano
authors.initials: F
authors.lastname: Falasconi
authors.forename: Alfonso
authors.initials: A
authors.lastname: Savio
authors.forename: Pasqualina
authors.initials: P
authors.lastname: Giordano
authors.forename: Gennaro
authors.initials: G
authors.lastname: Daniele
authors.forename: Mario
authors.initials: M
authors.lastname: Iaccarino
authors.forename: Maria Carmela
authors.initials: MC
authors.lastname: Piccirillo
authors.forename: Massimo
authors.initials: M
authors.lastname: Di Maio
authors.forename: Alessandro
authors.initials: A
authors.lastname: Morabito
authors.forename: Ciro
authors.initials: C
authors.lastname: Gallo
authors.forename: Francesco
authors.initials: F
authors.lastname: Perrone
mesh_terms: D002986:Clinical Trials as Topic; D017408:Guidelines as Topic; D006801:Humans; D007558:Italy; D015337:Multicenter Studies as Topic; D009939:Organizations, Nonprofit / Q000706:statistics & numerical data*