Section: New Software and Platforms

Clinical trial simulator

Participants : Marc Lavielle, Fazia Bellal, Célia Barthélémy.

A clinical trial simulator (CTS) enables effective implementation of the learn-and-confirm paradigm in drug development. Through simulations the anticipated success rate of a future trial can be estimated. For various reasons industry has not embraced currently available software for trial simulation. A new tool is essential for Model Based Drug Development (MBDD).

Popix is responsible for developing a new CTS within the DDMoRe project (see below). A new version of the CTS is available as a R package since December 2014. The capabilities of this new version comprise:

• Flexible study designs used in Phase 2 of clinical drug development: parallel group studies, crossover studies, complex treatments defined as a combination of different treatments

• Simulation of patients sampled from a joint distribution or using an external data file

• Simulation of exposure to the investigated drug and several types of drug effects related to drug exposure (continuous, categorical, count, time-to-event)

• Inter individual and intra individual variability models

• Graphics and statistical tests