Sponsor Institutions Committee
A consortium of 5 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
- University of Munster, Munster, Germany
- AMC/Rotterdam/DCOG, NL
The ITCC delivers a large number of academic-led, non-commercially sponsored clinical trials across the network of 54 ITCC clinical trial sites in 14 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. 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 with the Leading ITCC European sponsor. The Consortium also incluse Institutions who act as the sole, centralised ITCC 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 have collaborated to developharmonised procedures to facilitate the efficient delivery of academic-led trials across the ITCC network. The Committee and Consortium have implemented a standard template for clinical study agreements between sponosrs and national co-ordianting centres and are developing guidelines for writing trial protocols with country specific guidance
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.