This annual license fee is for a single designated desktop digital download license.
Requirements - Purchase of East Base Module
East PROGRAM simulates a sequence of clinical trials within an oncology program. One can simulate a dose escalation trial (3+3, mTPI, CRM, BLRM, from East ESCALATE) followed by a cohort expansion phase. Alternatively, one can simulate a single-arm Phase 2 trial followed by a two-arm Phase 3 two trial. Both alternatives allow for the incorporation of flexible Go/No-Go rules.
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.
Continuous, Discrete and Survival Endpoints