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Clinical trials in Italy: focus on the protocols submitted to ethics committees
F Venturini1, C Alberti, M P Alberti
1Servizio di Farmacia, Policlinico G.B. Rossi, Azienda Ospedaliera di Verona, piazzale L.A. Scuro 10, Verona, Italy. venturin@cmns.mnegri.it
Objective:
To describe the main characteristics of clinical research protocols submitted to Italian local ethics committees (LECs).
Design:
Prospective survey on all research protocols evaluated during the period from 1 September 1998 to 31 July 1999. Data were prospectively collected for each individual study containing information on: general characteristics of the study; study design; population under study; LEC decision; and study monitoring.
Setting:
Twenty Italian LECs from nine regions in Italy.
Main Outcome Measures:
Type of protocols, diseases and drugs under investigation, population under study, methodological characteristics (e.g. sponsorship, multicentricity, presence of a control group).
Results:
Data on 449 protocols corresponding to 625 evaluations were received. The majority of protocols (83.1%, n=373) were investigational studies on drugs, sponsored 76.8% (n=345) and multicentre 86.4% (n=388). The majority of the drug protocols were on antineoplastic drugs (27.7%, n=104), cardiovascular agents (15.4%, n=58) and systemic anti-infective agents (13.8%, n=52). A few of the drugs investigated were new entities. A few studies focused on subpopulations, e.g. elderly and children (10 and 16, respectively). Early development phases (I and II) were less likely to be sponsored and multicentre. The most represented drug category in phase I-II trials was the antineoplastic agents.
Conclusion:
A small portion of research protocols submitted to LECs in Italy relate to innovative research. The new Italian legislation, which decentralizes approval of clinical trials from central to local levels, will lead to shorter approval times and should stimulate more original research. Surveys on LECs activity give important information on active research areas, methodological quality of current studies and outcome of the studies in terms of trial closure and publication of the results. The latter information may be obtained through a follow-up of the cohort of studies included in the present cross-sectional survey.