eShowcase: Adaptive Trials Simulation Toolkit

Tessella (Newton, MA) Adaptive Trials Simulation Toolkit contains a range of adaptive clinical trial models for simulating different adaptive methods from Phase I through Phase III. The first release includes a NDLM dose finder and a Seamless Phase II/III Simulator.

Adaptive Trials Simulation Toolkit

The NDLM dose finder, specific to Phase II trials, simulates trials run using a Bayesian Model that is updated with response data as the trial runs. The NDLM is fitted to the response data and used to estimate whether any dose will fit the target criteria and which dose is most likely. It allows the model to recommend whether to continue the trial and which doses to favor in randomization.

Seamless Phase II/III Simulator offers an interim analysis between the two phases, where the treatment arms to be retained are selected and the sample size for the next phase calculated. This step saves time between Phase II and III, and allows for smaller Phase III trials.