Improving the prognostic value of early phase data is among one of several ways to increase the probability of successes in drug development, a process which has become more expensive as failure rates have risen, says an industry expert.
Certara has launched version 2.3 of its Trial Simulator software, which allows users to model and simulate different clinical trial scenarios – and supports the implementation of adaptive design.
New guidances from the FDA update language and provide clarity for innovative approaches to the design and execution of clinical trials, say industry executives.