Article Text

other Versions

PDF
Paper
Time required to start multicentre clinical trials within the Italian Medicine Agency programme of support for independent research
  1. Gianfranco De Feo1,
  2. Luciano Frontini2,
  3. Silvia Rota2,
  4. Antonio Pepe3,
  5. Simona Signoriello4,
  6. Roberto Labianca5,
  7. Alberto Sobrero6,
  8. Sabino De Placido3,
  9. Francesco Perrone7
  1. 1Scientific Direction, National Cancer Institute, Naples, Italy
  2. 2GISCAD Foundation, Parabiago, Italy
  3. 3Department of Endocrinology and Molecular Oncology, Federico II University, Naples, Italy
  4. 4Department of Mental Health and Preventive Medicine, Second University, Naples, Italy
  5. 5Department of Medical Oncology, Ospedali Riuniti, Bergamo, Italy
  6. 6Department of Medical Oncology, San Martino Hospital, Genoa, Italy
  7. 7Clinical Trials Unit, National Cancer Institute, Naples, Italy
  1. Correspondence to Dr Francesco Perrone, Clinical Trials Unit, National Cancer Institute, 80131 Naples, Italy; francesco.perrone{at}usc-intnapoli.net

Abstract

Background and aim 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.

  • Clinical Ethics
  • Ethics Committees/Consultation

Statistics from Altmetric.com

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.