Clinical Trials: Focus on Italy

Abstract

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 environment for 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, when general practitioners can be involved, and the role of the National Monitoring Centre for Clinical Trials in producing state-of-the-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.

Multicentre trials review process by research ethics committees in Spain: where do they stand before implementing the new European regulation?

“…This multiplication of effort is expensive, time consuming, and has resulted in too much variety in response among the RECs involved 1-3 10 In an attempt to solve this situation, the UK moved forward by establishing multicentre research ethics committees, with defined roles and responsibilities. 11 12 Although the British system has some limitations, 13 it may be considered as a step forward in the search for a rapid process compared with the situation in other countries, such as Spain 14 and Italy, 15 in which MCT protocols are reviewed in depth by all RECs involved. Because the development of a new medicine is a very competitive enterprise, involving considerable economic effort and requiring completion of the development programme within the shortest possible time, the European Commission has tried to ensure that European countries are competitive enough, in terms of time and quality, to attract investments in clinical research.…”