A randomized two arm study, using a utility weighted modified Rankin score and rules for adapting the enrolment criteria based on the location of the haemorrhage.

This FACTS Webinar will address RAR: 1) A surprising amount of the literature considers just the two arm setting, when arguably the most interesting setting for this technique is the multi-arm one. 2) Present some results in favor of RAR. 3) Lastly there are still misconceptions around that RAR inflates type-1 error, where it is easy to show that the opposite can be true.

Designing a phase 1 dose escalation using Bayesian Logistic Regression Model (BLRM), with open enrolment (rather than cohort) using FACTS N-CRM.

Using FACTS to design a two-arm study where differences in adherence between the arms drive the effect size. Uncertainty in the effect size prompted spacing the interims to correspond to different sample sizes resulting in irregular interim analyses. Using a uses a finite mixture model from previous data on the analysis endpoint to justify the irregular interims.

Is this the most complex and most successful trial ever designed and run? Looking at the AWARD 5 trial for what became Eli Lilly’s Trulicity drug. The drug used response adaptive randomization, longitudinal modelling, dose response modelling and a utility function combining 4 endpoints. The trial selected a successful dose and switched early from phase 2 to a successful phase 3.

Berry Consultants is hosting a free 6-week public webinar series on "Case Studies in using FACTS to design Clinical Trials" from October 17th to November 21st, 2024, featuring live demonstrations of trial design using their simulation software, with registration available for each session at their website.