Prof. Fabio Blandini
|The role of the Clinical Trial Center (CTC) is to support healthcare personnel in conducting clinical trials. This includes training healthcare personnel in the design and conduction of clinical trials, including compliance with Good Clinical Practice regulations, assistance in protocol development and grant applications, reviewing documentation to be submitted to the Ethics Committee (EC), interfacing with the EC secretariat and with sponsoring institutions and companies, ensuring compliance with regulatory requirements, and providing monitoring and auditing services as needed. As part of its role, the CTC is responsible for managing the Clinical Database, which involves keeping an updated record of all trials started or due to be started and key features such as type and number patients enrolled/ to be enrolled. The Clinical Database software also allows investigators and staff to access reliable data on the number and characteristics of the patients potentially eligible for inclusion in clinical trials. The CTC produces and distributes at regular intervals an internal newsletter to update researchers about clinical trials being conducted at the Mondino Foundation, and to facilitate collaborations, especially with regard to patient recruitment.
The CTC also works to promote the establishment of Foundation-led networks of clinical centers of excellence, in order to facilitate the conduction of multicenter clinical trials. The CTC, in particular, is actively involved in the planning and coordination of clinical studies of drugs used in the treatment of neurological disease, including:
Some of the CTC research activities are conducted in collaboration with a number of other centers in Italy and abroad, in close synergy with the Division of Clinical and Experimental Pharmacology of the Department of Internal Medicine and Therapeutics of the University of Pavia, with which the head of the CTC service is affiliated. The CTC also operates in synergy with EpiCARE (https://epi-care.eu/), the European Reference Network (ERN) for rare and complex epilepsies, of which the Institute is an integral part with a coordinating role in clinical trial activities.
Additional activities of the CTC include: