Clinical trials in Italy: focus on the protocols submitted to Ethics Committees

Objective: To describe the main characteristics of clinical research protoc ols submitted to Italian local ethics committees (LECs). Design: Prospective survey on all research protocols evaluated during the p eriod from 1 September 1998 to 31 July 1999. Data were prospectively collec ted for each individual study containing information on: general characteri stics 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 investig ation, population under study, methodological characteristics (e.g. sponsor ship, multicentricity, presence of a control group). Results: Data on 449 protocols corresponding to 625 evaluations were receiv ed. The majority of protocols (83.1%, n=373) were investigational studies o n drugs, sponsored 76.8% (n=345) and multicentre 86.4% (n=388), The majorit y of the drug protocols were on antineoplastic drugs (27.7%, n=104), cardio vascular 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 focus ed on subpopulations, e.g. elderly and children (10 and 16, respectively). Early development phases (I and II) were less likely to be sponsored and mu lticentre. 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 Ital y relate to innovative research. The new Italian legislation, which decentr alizes approval of clinical trials from central to local levels, will lead to shorter approval times and should stimulate more original research. Surv eys on LECs activity give important information on active research areas, m ethodological quality of current studies and outcome of the studies in term s of trial closure and publication of the results. The latter information m ay be obtained through a follow-up of the cohort of studies included in the present cross-sectional survey.