FACTS Capabilities

A summary of FACTS capabilities is below:

  • Supports clinical trial design process
    • Enables swift high level decisions on the trial design through being able to swiftly specify designs (no programming) and run simulations (the simulations run very quickly)
    • Makes successive refinement of the trial design easy, allowing the design to be optimized in terms of its key operating characteristics
    • Provides data for inclusion in a Simulation Report
  • Provides the following trial designs
    • Dose Escalation Designs: Phase 1/2a trials that are based on the CRM (Continuous Reassessment Method) and extensions:
      • The use of CRM designs with an efficacy endpoint, and designs with both an efficacy and toxicity endpoint
      • Allows a dichotomous co-variate (splitting the population into to populations or “samples”) to be included in the model
      • The use of an ordinal endpoint, 3 or 4 levels of toxicity.
      • An options for a ‘single-patient run-in’ then applying the standard CRM after the first toxicity
    • Bayesian Dose Finding Designs: Phase 2a/b trials where the endpoint is continuous, dichotomous or time-to-event. For each endpoint the following features are available:
      • Fixed or adaptive designs
      • Both Bayesian and Frequentist final analysis
      • Options to include dose response modeling and longitudinal modeling
      • Data can be simulated within the tool, or generated externally and supplied as a datafile of patient responses (e.g. from a PK-PD model)
      • Timing of interims (if any)
      • Time to endpoint and intermediate visits
      • If adaptive a range of adaptive strategies – early stopping, arm dropping, adaptive randomization
    • Bayesian Dose Finding Designs: Phase 2a/b trials with two endpoints either continuous or dichotomous. This has all the features of the single endpoint designs but allows the trial decisions to be driven by a utility function that can be defined to combine the two endpoints. Allowing trials combining two efficacy endpoints or an efficacy and safety endpoint to be designed.
  • Prototypes for Future Design Potential
    • Combination designs: Phase 1 trials which vary the dose of two drugs given in combination.
      • can be used on with NMEs or existing treatments
      • can include ‘prior’ data
      • can exclude specific combinations and ensure higher combinations are only ‘opened up’ when sufficient data has been collected on lower combinations
      • supports a variety of strategies for the ‘initial run-in’ and subsequent MTD combination finding stage