Gianfranco De Feo1, Luciano Frontini2, Silvia Rota2, Antonio Pepe3, Simona Signoriello4, Roberto Labianca5, Alberto Sobrero6, Sabino De Placido3, Francesco Perrone7. 1. Scientific Direction, National Cancer Institute, Naples, Italy. 2. GISCAD Foundation, Parabiago, Italy. 3. Department of Endocrinology and Molecular Oncology, Federico II University, Naples, Italy. 4. Department of Mental Health and Preventive Medicine, Second University, Naples, Italy. 5. Department of Medical Oncology, Ospedali Riuniti, Bergamo, Italy. 6. Department of Medical Oncology, San Martino Hospital, Genoa, Italy. 7. Clinical Trials Unit, National Cancer Institute, Naples, Italy.
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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Authors: Asgar H Rishu; Nicole Marinoff; Lisa Julien; Mariana Dumitrascu; Nicole Marten; Shauna Eggertson; Su Willems; Stacy Ruddell; Dan Lane; Bruce Light; Henry T Stelfox; Philippe Jouvet; Richard Hall; Steven Reynolds; Nick Daneman; Robert A Fowler Journal: J Crit Care Date: 2017-03-01 Impact factor: 3.425
Authors: Zakira Naureen; Tommaso Beccari; Robert S Marks; Richard Brown; Lorenzo Lorusso; Derek Pheby; Stanislav Miertus; Karen L Herbst; Liborio Stuppia; Gary Henehan; Benedetto Falsini; Ludovica Lumer; Munis Dundar; Matteo Bertelli; International Bioethical Study Group Journal: Acta Biomed Date: 2020-11-09