Traduction de «early phase trials as defined » (Néerlandais → Français) :

In the course of 2008 there were at least another 99 early phase trials of which 43 trials being carried out for the first time in humans, 164 phase I trials (including those not falling under the definition of an early phase trial), 176 phase II trials and 223 phase III trials. The database currently does not always allow a distinction to be made between early phase trials as defined above and later phases.
In the course of 2008 there were at least another 99 early phase trials of which 43 trials being carried out for the first time in humans, 164 phase I trials (including those not falling under the definition of an early phase trial), 176 phase II trials and 223 phase III trials. The database currently does not always allow a distinction to be made between early phase trials as defined above and later phases.

However, the figures do clearly show that there is a considerable number of early phase trials. There are 7 units in Belgium actively undertaking phase I clinical trials and a number of early phase trials are being conducted in centres where there is expertise in specific clinical areas.
However, the figures do clearly show that there is a considerable number of early phase trials. There are 7 units in Belgium actively undertaking phase I clinical trials and a number of early phase trials are being conducted in centres where there is expertise in specific clinical areas.

The number of early phase trials is per capita one of the highest in Europe. Since the publication of the guideline trials for conducting explorative studies in Belgium, in mid June 2007, 25 applications for conducting these clinical trials have been submitted to the FAMHP.
The number of early phase trials is per capita one of the highest in Europe. Since the publication of the guideline trials for conducting explorative studies in Belgium, in mid June 2007, 25 applications for conducting these clinical trials have been submitted to the FAMHP.

For phase I studies, and therefore the large majority of early phase trials, the statutory time limit amounts to just 15 days.
For phase I studies, and therefore the large majority of early phase trials, the statutory time limit amounts to just 15 days.

Furthermore, the Agency intends to take a leading role in producing guidelines for these early phase trials.
Furthermore, the Agency intends to take a leading role in producing guidelines for these early phase trials.

Reasons for not approving early phase trials immediately
Reasons for not approving early phase trials immediately

in healthy volunteers and patients. This entails investigating the safety and efficacy of increasing doses of the product and the pharmacokinetics in phase I and early phase II trials.
in healthy volunteers and patients. This entails investigating the safety and efficacy of increasing doses of the product and the pharmacokinetics in phase I and early phase II trials.