Scientific Director’s Office
Ethics Committee
Data Management
Clinical research activity in IEO decreased during 2012. Overall 76 new clinical trial applications were evaluated in 7 plenary sessions of the Ethics Committee (EC). A favorable opinion was expressed in more than 95% of the cases, while the scientific aspects, the expected improvement of the general health and well being and the overall risk/benefit ratio for the participants, were the principal aspects considered by the Committee in the evaluation of these trials. The EC opinion was expressed within 15 days for most of the applications and it was registered in the national clinical trials database in less than 5 working days. The applications for substantial amendments on ongoing trials were 154 for this year and were reviewed and approved with a mean evaluation time of 10 days. The therapeutic use of drugs still under investigation in clinical trials, for advanced cancer patients, was approved for 11 products and for a total number of 66 patients. The composition of the Committee was partially reviewed and the new composition was accredited at the Ministry of Health, the National Drug Agency as well as the Lombardy Region. The Ethics Committee renewed also the Federal Wide Assurance by the Office for Human Research Protections of the U.S Department of Health and Human Services. With great sorrow we report that Dr Leonardo La Pietra, Medical Officer of IEO and member of the Committee, died on December 2011.
The Data Management (DM) Office is responsible for high quality collection and processing of clinical research data, offers support for their analysis and publishing, and gives an important contribute to the administrative set up, management and reporting of clinical trial results. The main goal is to ensure individualised care to all the patients participating in the trials. The DM Office is composed of 22 data managers, 8 fellowship data managers, and 5 data entry clerks. During 2012 the DM Office has supported the activation of 61 new clinical trials and the conduction of 312 ongoing clinical trials (phase I, II, III, IV, observational and others). 72% of all the clinical trials are sponsored by external agencies, while 28% are financed by IEO; overall, 50% of the studies are international multicenter trials and the remaining ones are either national multicenter trials (26%) or monocenter trials (24%). Specific responsibilities are: screening and overseeing of data accrual, supervision of the scheduling of study interventions and follow-ups, supervision of data collection and processing, compliance with relevant Institutional or governmental regulatory guidelines in the conduct of clinical research, assistance in the interactions with research staff both at the Institute and at other collaborating institutions, coordination of protocol production and submission of regulatory documents to the Ethics Committee and regulatory bodies, monitoring of patients and test result reporting, and assistance in the preparation of research reports and manuscripts for publication and presentations. Several procedures ensure the correct execution of these activities. They include internal Standard Operating Procedures such as the use of Case Report Forms (CRFs) and Database Management, Data Entry process, Patients Registration, Data Manager training. In the last year, we have introduced and developed another important element: the “Collaboration project”; in fact, due to the large amount of clinical trials, the collaboration
Ethics Committee As from May 2013
Luciano MARTINI Chairman Giovanni APOLONE Vice Chairman Atanasio NONIS Secretary Maria Santina BONARDI Natale CASCINELLI Giuseppe GALLUS Stefano GASTALDI Aaron GOLDHIRSCH Pasquale MICCINELLI Francesca MERZAGORA Emanuela OMODEO SALE’ Maurizio PELLEGRINI Enrico RAMBALDI FELDMANN Oliviero RINALDI Nicole ROTMENSZ Umberto VERONESI
SECRETARIAT Daniela TAMAGNI OBSERVER Mauro MELIS
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IEO — Scientific Report 2012 — Ongoing Research 2013
Scientific Director’s Office
Scientific Director’s Office
between data managers, clinical staff and all the people involved in a particular trial has become a key factor to improve the quality of trial management. In addition, a specific tool that allows, directly on the IEO Intranet website, access to the clinical trials and to the relevant documentation is available. By this tool, all the members of a research team can find out which clinical trials are on-going in the different Clinical Units/Divisions and how to access them.
IEO — Scientific Report 2012 — Ongoing Research 2013
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