February 24, 2019

MUCE

Multiple Doses/Multiple Indications Cohort Expansion


MUCE (Multiple Cohort Expansion) is at the core of the BEST platform. It allows for expansion of multiple doses in multiple indications, which is an efficient and economical solution for dose and indication findings in clinical trial phase 1b. MUCE is based on a proprietary BHM (Bayesian Hierarchical Model) and makes full use of inter-dose and inter-indication information for statistical inference. Due to the novel BHM, MUCE can improve the overall study power in selecting the promising doses and indications for late-stage drug development and eliminate toxic or inefficacious doses quickly without wasting resources. This leads to increased probability of success for the entire drug development, speeds up the development process, and reduces the cost for sponsors.

Benefits

——Compared to the conventional approach (independent frequentist test for each dose-indication arm)

  1. [Smaller sample size] The BEST platform is able to save about 20%-30% sample size for the trial without sacrificing the chance of finding the efficacious doses and promising indications.
  2. [Higher power] The BEST platform has a larger (up to twice many) chance to find the efficacious dose and promising indications.
  3. [Greater Flexibility] The BEST platform is highly flexible, incorporating choice of interim analyses that allow early stop of cohort expansion for inefficacious or overly toxic dose.