It is often necessary to pool safety data from late phase studies, in preparation for regulatory submission. Some of our clients have also begun to add Phase 1 safety data to this pool. On some occasions this is required by regulators. In many cases, however, these Phase 1 data simply provide further evidence that a new therapeutic lives up to the promise of safety across patient populations.
Oct 19, 2015 5:15:40 PM
Dec 4, 2014 11:30:00 AM
Fulyzaq® from Napo/Salix was the first drug ever to be approved using an adaptive two-stage "seamless" clinical trial design. However, when Napo Pharmaceuticals sought orphan drug status for Crofelemer (made from the croton lechleri plant, pictured above left), it received a short window from the FDA in which to complete a Phase 3 trial for safety and efficacy. Aiming to diminish both time and...
Nov 4, 2014 8:30:00 AM
A key stage of exploratory drug development is implementing a proof-of-concept study to demonstrate the safety of a drug. Given the importance of accurate dose-finding for Phase 3 success, methodological improvements to proof-of-concept studies in Phase 2 can translate into greater likelihood of getting a drug to market.
Apr 24, 2014 11:00:00 AM
Here at Cytel we firmly believe that if you don’t get the design of a clinical program right, then nothing else matters. A study recently published by the Journal of the American Medical Association, once again confirms the vital importance of proper trial design for the timely approval of a new drug. The article reports that nearly half of all submitted NME applications fail upon first...