Sponsor Institutions Committee
A consortium of ITCC institutions was created in 2014 to share the administrative burden of European sponsorship for ITCC academic-trials and to establish harmonized procedures for ITCC academic trials:
- CRTCU, Birmingham, UK
- Gustave Roussy, Villejuif, France
- Centre Léon Bérard, Lyon, France
- Institut Curie, Paris, France
- CHU de Nantes, Nantes, France
- University of Munster, Munster, Germany
- Heidelberg University Hospital, Heidelberg, Germany
- Princess Maxima Center, Utrecht, NL
The ITCC delivers a large number of academic-led, non-commercially sponsored clinical trials across the network of over 50 ITCC clinical trial sites in 16 countries. These trials are developed, managed and sponsored by academic Institutions within ITCC, working in collaboration with the clinical investigators.
There are substantial practical and regulatory challenges to delivering multi-country, multi-site clinical trials, mainly due to national differences in processes. The ITCC Sponsoring Institutions Committee comprises a network of academic institutions that have the infrastructure and expertise to act as European Sponsors for ITCC early phase paediatric oncology trials.
In addition, we have established an ITCC National Coordinating Centres Consortium who are ITCC institutions who can take on the role of coordinating the delivery of the trial in the sites in their country, working in collaboration with the Leading ITCC European sponsor. The Consortium also incluse Institutions who act as the sole, centralised ITCC recruiting site for their country.
The ITCC Sponsoring Institutions and National Coordinating Centres are selected based on their experience and expertise following a call for Expression of Interest and evaluation of applications by an Independent Review Committee.
The members of the ITCC Sponsoring Institutions Committee and Consortium of National Coordinating Centres collaborate to share information on national requirements and procedures and to develop aligned guidance documents to facilitate the efficient delivery of academic-led trials across the ITCC network. The Committee and Network have implemented standard operating procedures for sponsor/national coordinating centers and trial site selection and for the initial trial set up meetings to facilitate early engagement across the network. A standard template for clinical study agreements between Sponsors and National Coordinating Centers has been agreed and we are developing guidelines for other processes including writing trial protocols with country specific guidance and costing for trials.
The ITCC Sponsoring Institutions Committee has oversight of the pathways for selection of academic sponsors and national coordinating centres for ITCC academic sponsored trials and the review of the quality of sites delivering trials within the ITCC network.