title: How a Clinical Trial Unit can improve independent clinical research in rare tumors: the Italian Sarcoma Group experience.
abstract: BACKGROUND
  The Italian Sarcoma Group (ISG) is a nonprofit group of professionals established in 1997 aimed to improve the quality of care and promote the independent research in sarcomas. The increased regulatory requirements, the chance to increase the number of trials with other cooperative groups and an interest from pharmaceutical companies in supporting independent research, generated the need of an internal service for research management.
  
  
  RESULTS
  In 2010, ISG implemented in its organization a Clinical Trial Unit (CTU). The CTU was appointed to fully manage Clinical Trial Operations, to guarantee regulation compliance and provide a central support to the investigators, fostering a collaboration both at national and international level. In 2016 ISG promoted 25 studies in about 120 centers, with a fivefold increase in the last 5 years: 68% were interventional and 32% observational. Nine of the 17 interventional studies (52%) were supported by pharmaceutical companies, while 4 (24%) were funded by European Commission within specific projects on sarcomas and 4 (24%) were supported by the ISG itself.
  
  
  CONCLUSIONS
  The contribution of ISG researchers to the international community was striking from the earliest years of the ISG creation. The challenges of the regulatory clinical research scenario, which imposes solid and hard-fast methodology with deep knowledge and expertise, highlighted the need to identify qualified and dedicated experts able to run and follow the multifaceted aspects of trials. Our analysis demonstrated how this model has led to a growth in competitiveness of the group. The collaboration between clinicians and CTU made possible to support the research with high scientific and ethical standards and to increase the number of trials, sites and overall enrolled patients. The reduced time for approvals, the continuous support to sites, the increased speed in data collection and analysis make the ISG research attractive for pharmaceutical industries, despite the problems that have characterized the independent research in the last years. The ability to fully manage and oversight Clinical Operations and the high quality of delivered services, have led the ISG to be recognized as a reliable partner and coordinator within the international sarcoma networks.
authors.affiliation: Italian Sarcoma Group, Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136 Bologna, Italy.
authors.forename: Emanuela
authors.identifier: 0000-0003-3504-5631
authors.initials: E
authors.lastname: Marchesi
authors.affiliation: Division of Medical Oncology, Candiolo Cancer Institute-FPO, IRCCS, Candiolo, Italy.
authors.forename: Celeste
authors.initials: C
authors.lastname: Cagnazzo
authors.affiliation: Italian Sarcoma Group, Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136 Bologna, Italy.
authors.forename: Irene
authors.initials: I
authors.lastname: Quattrini
authors.affiliation: Chemotherapy Unit, Orthopedic Rizzoli Institute, Bologna, Italy.
authors.forename: Martina Piccinni
authors.initials: MP
authors.lastname: Leopardi
authors.affiliation: Adult Mesenchymal Tumour and Rare Cancer Medical Oncology Unit, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Villa
authors.affiliation: Division of Medical Oncology, Candiolo Cancer Institute-FPO, IRCCS, Candiolo, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Grignani
authors.affiliation: Division of Medical Oncology, Candiolo Cancer Institute-FPO, IRCCS, Candiolo, Italy.
authors.forename: Lorenzo
authors.initials: L
authors.lastname: D'Ambrosio
authors.affiliation: Adult Mesenchymal Tumour and Rare Cancer Medical Oncology Unit, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Stacchiotti
authors.affiliation: Adult Mesenchymal Tumour and Rare Cancer Medical Oncology Unit, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.
authors.forename: Paolo Giovanni
authors.initials: PG
authors.lastname: Casali
authors.affiliation: Laboratory of Experimental Oncology, Orthopedic Rizzoli Institute, Bologna, Italy.
authors.forename: Piero
authors.initials: P
authors.lastname: Picci