Head

Prof. Fabio Blandini

Phone

0382 380416

Mail

fabio.blandini@mondino.it

Curriculum Blandini

  • Collaborators

    1 neurologist, with the role of technical-scientific coordinator: Grazia Sances

    1 clinical neuropharmacologist: Cinzia Fattore (research fellow)

    1 nursing team manager: Monica Bianchi

    3 research nurses: Luciana Gracardi, Simona Lunghi, Veronica Tosca

  • Location

    Building 2, Floor −1

    Phone: 0382 380818

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:

  • comparative studies of the efficacy and tolerability of investigational and established drugs;

  • pharmacokinetic studies and drug interaction studies;

  • observational studies, particularly those aimed at assessing clinical outcomes and in particular the adverse effects of treatments;

  • pharmacoutilization and pharmacoeconomics studies.

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:

  • assisting Institution personnel and trainees in identifying sources of funding for clinical research and facilitating access to the same;

  • organizing telemedicine and tele-assistance systems in areas where these are needed to support activities in which the CTC is involved;

  • promoting observational and interventional studies in areas of interest to the Mondino Foundation (headache, epilepsy, rare diseases, Parkinson’s disease, multiple sclerosis, stroke), by drafting independent clinical research protocols;

  • taking part in the promotion of guidelines by the Foundation and/or in guideline development initiatives, in collaboration with the Italian Ministry of Health, the Italian National Agency for Regional Healthcare Services (AGENAS), the Lombardy regional government, the Association of Italian Medical-Scientific Societies (FISM), and international scientific societies, such as the International League against Epilepsy, in topic areas relevant to the aims of the CTC;

  • organizing clinical research training courses aimed specifically at postgraduate trainees and medical and paramedical staff interested in clinical trials.