Clinical Trials: Focus on Italy
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0092-8615/2002 Copyright 0 2002 Drug Information Association Inc.
CLINICAL TRIALS: FOCUS ON ITALY WALTERBIANCHI,MD Medical Director, UCB Pharma S.p.A.. Pianezza (TO), Italy
PIA FURLANI Regulatory Affairs Officer, Zambon Italia Srl, Bresso, Milan, Italy
TIZIANAALESSI Regulatory Affairs Manager, Doc Generici Srl. Milan, Italy
CINZIABASCARIN Associate Director, Regulatory Affairs, Gilead Sciences Srl, Milan, Italy
LUISELLA MAJORI Regulatory Affairs Manager and Local Safety Officer, Fujisawa Srl, Milan, Italy
The recent introduction of new rules for the involvement of general practitioners in clinical trials in Italy, and the less recent decentralization process, have affected clinical investigations and regulatory activity. Regulatory affairs professionals and clinical researchers have had to become acquainted with a new, more dynamic, and more flexible environmentfor clinical trials that still guarantees high-quality protection to trial subjects. The regulatory environment for clinical trials in Italy has improved dramatically, supported by the authorities’ continuous effort to improve the rules. Italy now attracts more innovative investigations. We summarize when, how, and where decentralized or centralized control of clinical trials is exerted, w k n general practitioners can be involved, and the role of the National Monitoring Centre for Clinical Trials in producing state-ofthe-art on-line registers of clinical trial reports. We concluded that Italy has definitely left delays and bureaucracy behind, and is now ready to play a major role in clinical drug development and to provide an important contribution to innovative, original clinical investigations. Key Words: Clinical development; Clinical trial authorizations;Ethical committees; Legislation; General practitioners
INTRODUCTION THE IMPORTANT CHANGES introduced in the Of clinical research have Pmmptd the ltalian Association Of to create a working goup aimed at monitoring
Reprint address: Walter Bianchi, Medical UCB Ph-a s . ~ . A . ,Via hagha, 15, 10044 pianezza (TO),Italy. E-mail:[email protected].
the regulatory environment of clinical trials. This paper is a result of the work of this group. An inquiry (1) held years ago showed that Italy had all the necessary qualifications (scientific know-how and competitive costs) to be considered an interesting country for carrying out clinical investigations in drug development. Nevertheless, the disadvantages (delayed authorizations and heavy bureaucracy) hindered adequate development in this field for a long time (1). The
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W. Bianchi, P . Furlani, T. Alessi, C. Bascarin, and L. Majori
potential for Italy to participate in clinical investigations was also emphasized in a subsequent work (2), which described Italy’s overall regulatory environment. The implementation of several decrees issued between 1998 and 2001, which allowed decentralization to the local ethical committees of most parts of the procedures formerly within the direct authority of the Ministry of Health and enabled general
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