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INTRODUCTION What is OsSC A public information tool for Italian clinical trials on medicines A link with EudraCT.

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Presentation on theme: "INTRODUCTION What is OsSC A public information tool for Italian clinical trials on medicines A link with EudraCT."— Presentation transcript:

1 INTRODUCTION What is OsSC A public information tool for Italian clinical trials on medicines A link with EudraCT and Eudravigilance An important window for Italian clinical research What does it contain List of Italian clinical trials / Ethics Committees / certified private sites Whom does it inform Ethics Committees / Sponsors / CROs / clinical researchers / Local Health Units / competent authorities / people Control activities Avoiding identical research projects Fostering uniformity and harmonization of local authorization procedures Defending citizens and patients, improving transparency, credibility and access to clinical research Support activities Supplying clinical trial sites physicians, paramedical and administrative personnel with training and information Fostering administrative simplification Speeding up authorization procedures Guideline activities Bringing up to date rules in order to promote standardization and quality of processes Determining priority sectors in the field of health care in which furthering and assisting clinical research MATERIALS AND METHODS Goals Creating a real network among health professionals Modernizing the Italian system of applied research in the health field Encouraging investments in clinical research in Italy Promoting phase I and II trials Giving unquestionable references to those who work in the clinical research branch Information collected for each study General information, i.e.: Protocol title, code and file Sponsor and participating institutions Study design (phase, randomization, etc.) International Code Disease, MedDRA Drug(s) information (name, dosage, route, etc.) Eligibility (inclusion and exclusion criteria) Study population (age, gender) and duration of the study Administrative information, i.e.: Study evaluation (date, approval/rejection, etc.) Opening of the study for subjects enrolment Study status (open/ongoing/closed) and patients accrual Conclusion of the study and results Official publications Annual Report on clinical trials in Italy Bulletin on clinical trials in Italy (periodical updating) (also available on-line on the OsSCs web site) CONCLUSIONS OsSC is a snapshot of Italian clinical research and a leading instrument capable of identifying less investigated therapeutic areas and promoting specific projects in order to meet patients demands. Could OsSC be something more? A place for scientific discussions A network facilitating information interchange and fast communications among all the trials participants (ECs, Sponsors, Competent Authorities) On-going update for professional users On-line Journal RESULTS The Italian Monitoring Centre for Clinical Trials: an effective tool and source of information Clinical trials per therapeutic branch Clinical trials per year Clinical trials per Sponsor type: profit / no profit Agenzia Italiana del Farmaco - Italian Medicines Agency Rome, ITALY Clinical Trial Unit - Tomino Carlo, Aita Paola, Barchetti Maria Federica, Caciolli Sergio, Coppari Roberta, de Gregori Simona, De Nigro Luca, Galluccio Antonio, Guglielmi Fulvia, Marchetti Marisa, Misticoni Consorti Adele, Raimondo Simonetta, Russo Maria Elena


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