Program Simulations

This module will allow you to simulate sequence of clinical trials by using frequentist or Bayesian Go-NoGo Rules and other design options.

Program design consisting of dose escalation followed by cohort expansion

East can simulate a clinical development program consisting of a dose escalation study followed by a cohort expansion. In the dose escalation phase, the goal is to determine the maximum tolerated dose (MTD). East allows the user to choose between the 3+3, the modified toxicity probability interval (mTPI), continual reassessment method (CRM), or Bayesian logistic regression model (BLRM) designs. In the cohort expansion phase, go no-go decisions are taken based on pre-specified criteria for efficacy. East allows the user to specify a Bayesian or frequentist go no-go criteria for single mean or single proportion or single survival endpoint.

Program combining multiple trials

East offers users the ability to simulate a clinical development program combining two trials. The first trial can be a single- or multi-look single proportion design, Simon’s two stage design or a single- or multi-look logrank test given accrual duration and study duration design for survival endpoint (SU2SLRSD). The second trial is simulated only if the first trial is a success. The second trial is then simulated as a SU2SLRSD. East allows specification of the time duration between the end of the first trial and the beginning of the second trial. East will compute operating characteristics for the entire program after simulating both trials.

Features

  • Simulate a dose escalation design followed by cohort expansion study
    • Stage1: Dose escalation design (3+3, mTPI, CRM, BLRM)
    • Stage2: Single-arm cohort expansion
    • Frequentist or Bayesian GNG rules
  • Program combining multiple trials
    • Stage1: Single-arm binomial, Simon’s two-stage, or 2-arm survival
    • Stage2: A group sequential design
    • Specification of the time duration between the end of the first trial and the beginning of the second trial.

Benefits:

  • Computes the operating characteristics for the entire program after simulating both trials.
  • Optimizes the sequence of trials for a particular set of drug program objectives

Availability

Continuous, Discrete and Survival Endpoints