title: Time required to start multicentre clinical trials within the Italian Medicine Agency programme of support for independent research.
abstract: OBJECTIVE
  Time allowed for independent ethics committees (IECs) and administrative offices to assess and activate clinical trials is regulated by law. This study aims to describe time spent activating two multicentre non-profit trials supported by the Italian Medicines Agency (AIFA). Five non-AIFA supported (NAS) trials were used as a benchmark.
  
  
  METHODS
  The two AIFA-supported trials were FATA-GIM3 (optimal adjuvant hormonal treatment for breast cancer) and TOSCA (duration of adjuvant FOLFOX in colorectal cancer). The five NAS trials focused on lung or ovarian cancer. The following were measured for all trials: date of submission of trial documentation to peripheral IEC, date of IEC opinion and date trial contracts were signed. Times are reported in months.
  
  
  RESULTS
  106 centres applied to participate in FATA-GIM3 and 137 in TOSCA. An IEC opinion was issued by 100/106 (1 negative opinion) and 137/137 (2 negative opinions) centres, with a median time from submission of 3.6 months (range 0.1-60.2). After a positive IEC opinion, the median time before signing the trial contract was 3.3 months (0.1-59.2). Contracts were signed with 93/99 and 135/135 centres, with a median time from submission of study documentation of 8.4 months (0.5-61.1). Times for NAS trials were not substantially different.
  
  
  CONCLUSIONS
  FATA-GIM3 and TOSCA centres were opened after a median of 8 months, consisting of nearly 4 months each for IEC opinion and administrative signature, similar to the NAS trials. The process of trial activation in Italy remains inefficient and takes far longer than legally allowed.
authors.affiliation: Scientific Direction, National Cancer Institute, Naples, Italy.
authors.forename: Gianfranco
authors.initials: G
authors.lastname: De Feo
authors.affiliation: GISCAD Foundation, Parabiago, Italy.
authors.forename: Luciano
authors.initials: L
authors.lastname: Frontini
authors.affiliation: GISCAD Foundation, Parabiago, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Rota
authors.affiliation: Department of Endocrinology and Molecular Oncology, Federico II University, Naples, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Pepe
authors.affiliation: Department of Mental Health and Preventive Medicine, Second University, Naples, Italy.
authors.forename: Simona
authors.initials: S
authors.lastname: Signoriello
authors.affiliation: Department of Medical Oncology, Ospedali Riuniti, Bergamo, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Labianca
authors.affiliation: Department of Medical Oncology, San Martino Hospital, Genoa, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Sobrero
authors.affiliation: Department of Endocrinology and Molecular Oncology, Federico II University, Naples, Italy.
authors.forename: Sabino
authors.initials: S
authors.lastname: De Placido
authors.affiliation: Clinical Trials Unit, National Cancer Institute, Naples, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Perrone
mesh_terms: D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use; D019985:Benchmarking; D001943:Breast Neoplasms / Q000188:drug therapy; D002986:Clinical Trials as Topic / Q000592:standards*; D015179:Colorectal Neoplasms / Q000188:drug therapy; D017041:Ethics Committees / Q000592:standards; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007558:Italy; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D015337:Multicenter Studies as Topic / Q000592:standards*; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D013997:Time Factors
chemical_list: D018931:Antineoplastic Agents, Hormonal; D009944:Organoplatinum Compounds; D002955:Leucovorin; D005472:Fluorouracil
keywords: Clinical Ethics; Ethics Committees/Consultation