Guo et al. The design, analysis and application of mouse clinical trials in oncology drug development. BMC Cancer 2019; 19:718
Mouse clinical trials (MCTs) employ panels of preclinical models in population-based efficacy studies to evaluate potential anticancer therapeutics. MCTs mimic clinical trials, using models such as highly predictive patient-derived xenografts (PDX), or syngeneics for immuno-oncology studies.
Although these trials are widely used in preclinical oncology drug development, a statistical framework for MCTs is not yet established. MCTs are often analyzed by clinical trial methods, although the trial types differ in certain ways.
This publication establishes a statistical framework for MCTs and provides general guidelines on their design, analysis, and application.
Download This Publication To Understand:
- New methods making the design and analysis of MCTs more rational, flexible, and powerful, enabling MCTs to be a better tool in oncology R&D
- The relationship between mouse number and measurement accuracy for categorical and continuous efficacy endpoints
- Case studies demonstrating the advantages of linear mixed models (LMMs) in discovering biomarkers and exploring drug mechanisms of action
- How MCTs can explain discrepancies in clinical trial results