A record 730 clinical trials were approved in Italy last year, 11.8% more than in 2005. While other European countries such as the UK worry about a loss of clinical trial business to low-cost emerging markets, Italy saw its biggest rise in study approvals over the seven years of data released by the national medicines agency, AIFA (Agenzia Italiana del Famaco).

The number of clinical trial approvals in Italy has been climbing since 2002, when the tally dropped by 6.7% from the previous year to 569. Subsequently, there were 579 studies approved in 2003, 620 in 2004 and 653 in 2005. The data from the national monitoring centre OsSc (Osservatorio Nazionale sulla Sperimentazione Clinica dei medicinali) also show a gradual rise in the number of approved Phase II trials during the last four years, while the number of Phase III studies has declined over the same period.

In 2006, Phase II trials accounted for 39.5% of all studies approved in Italy and Phase III trials for 46.2%. That compared with 35.8% and 49.3% respectively in 2005 and with 34.9% and 53.9% respectively in 2003. Phase I studies made up just 2.3% of the total in 2006 (2.1% in 2005) and Phase IV post-marketing trials 9.7% (11.3%). A further 2.3% of trials approved last year were bioequivalence/bioavailability studies.

While large-scale international clinical trials have gained ground over the last seven years at the expense of national trials, most of this trend occurred between 2000 and 2003, the data show.

International versus national remains static

In the past three years the distribution of international versus national studies has remained more or less static. In 2006 there were 414 international multicentre trials and 158 national multicentre trials, accounting for 72.4% and 27.6% of the total. The same percentages were recorded in 2005, while in 2004 international studies made up 72.5% of the total and national studies 27.5%.

Excluding Phase I studies, pharmaceutical companies have sponsored 71.9% of all clinical trials approved in Italy over the last seven years, with non-profit entities such as hospitals, public or private research institutes and universities making up the balance. In 2006, however, trials sponsored by non-profit entities accounted for more than 35% of the total, helped by over €30 million in AIFA grants for independent research.

The top five pharmaceutical company sponsors of clinical trials in Italy during 2000-06 were Novartis (231 trials), GlaxoSmithKline (180), Roche (134), Pfizer (132) and Sanofi-Aventis (118).