Long, costly drug development timelines are putting pressures on biopharm companies and, as such, have the potential to restrict supply of new treatments.
“The traditional clinical trial approach, Phase I, II, III and IV, will have to be redesigned to investigate tolerability, safety and efficacy”, writes Carlo Tomino, of the Italian Medicines Agency (AIFA).
Tomino calls for a public debate on how clinical trials can be changed to accelerate development while ensuring patient safety. To stimulate debate Tomino proposes a hypothetical development process.
In the hypothetical scenario registration would be granted after a drug has passed through Phase 0, exploratory studies and confirmatory studies. However, registration would be tied to certain conditions and be followed by mandatory confirmation studies.
Expanding and intensifying post-marketing, which Tomino calls mandatory confirmation studies, would produce more real-world safety and efficacy data.
Trials in Italy 2000 – 2008
The number of clinical trials conducted in Italy, as shown below, increased from 2000 to 2008. However, the fairly consistent rise in the number of trials conducted in Italy masks a shift in the type of work being performed.
In 2000 more than 60 per cent of trials conducted in Italy were Phase III. By 2008 this figure had declined to 45 per cent. Phase I, II and IV all accounted for a greater proportion of clinical trials in 2008 than 2000.
