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.