East Trial Design Software

East 6.5 Base

$ 276.00

This annual license fee is for a single designated desktop digital download license. 

Academic pricing.

East 6.5 Module: Adapt

$ 708.00

This annual license fee is for a single designated desktop digital download license.

Academic pricing.

Requirements - Purchase of East Base and Sequential Modules

ADAPT is an East module for planning, simulating, monitoring, and communicating clinical trial designs that incorporate un-blinded sample size re-estimation rules. ADAPT provides a wide variety of options for normal and binomial endpoints, with strong control of the type-1 error rate. ADAPT includes hypothesis testing and adjusted inference based on methods by Cui, Hung, and Wang (1999), Mueller and Schafer (2001), Chen, DeMets, and Lan (2004), Gao, Ware and Mehta (2008), and the Promising Zone Design approach of Pocock and Mehta (2010).

View software license agreement here:

http://www.cytel.com/software-solutions/east/terms

East 6.5 Module: Endpoints

$ 216.00

This annual license fee is for a single designated desktop digital download license.

Academic pricing.

Requirements - Purchase of East Base 

ENDPOINTS is an East module for the design, simulation, and analysis of studies that need to test multiple endpoints. Using a variety of multiple testing procedures, and including both serial and parallel gatekeeping procedures (Dmitrienko and Tamhane, 2007), ENDPOINTS ensures you have the right strategy for the strong control of type-1 error given multiple endpoints testing. Optimize the testing strategy to obtain the best operating characteristics to meet your goals.

View software license agreement here:

www.cytel.com/software-solutions/east/terms

East 6.5 Module: Escalate

$ 708.00

This annual license fee is for a single designated desktop digital download license.

Academic pricing.

Requirements - Purchase of East Base

ESCALATE is an East module for the design, simulation, and monitoring of modern dose-escalation clinical trials. Evaluate and compare the operating characteristics of your designs under different assumptions about the dose-toxicity profile. Provide optimal dose recommendations for the next cohort of patients based on accumulating data. Clearly communicate critical information to clinicians to guide dosing decisions. Model-based dose-escalation methods in this module include the Continual Reassessment Method (mCRM; Goodman et al., 1995),  the Bayesian logistic regression model (BLRM; Neuenschwander et al., 2008), and the modified Toxicity Probability Interval (mTPI; Ji et al., 2010). 

View software license agreement here:

www.cytel.com/software-solutions/east/terms

East 6.5 Module: Exact

$ 216.00

This annual license fee is for a single designated desktop digital download license.

Academic pricing.

Requirements - Purchase of East Base

EXACT is an East module for the design, simulation, and monitoring of binomial response trials using exact distributional assumptions, with particular application to phase 2 single-arm screening trials in oncology.  EXACT utilizes the powerful engines of StatXact, to perform sample size and power calculations for clinical trials that require exact tests for binomial superiority, non-inferiority, and equivalence designs. Includes exact single-stage (A’Hern, 2001), both optimal and mini-max two-stage (Simon, 1989), and group sequential designs for single-arm studies.

View software license agreement here:

www.cytel.com/software-solutions/east/terms

East 6.5 Module: MultiArm

$ 96.00

This annual license fee is for a single designated desktop digital download license.

Academic pricing.

Requirements - Purchase of East Base

MULTIARM is an East module that offers the ability to plan, simulate, analyze, and communicate multi-arm fixed sample clinical trial designs. MULTIARM provides a wide variety of multiple testing procedures for the strong control of family-wise type-1 error rate when comparing multiple treatment arms to a control for Normal and Binomial endpoints.

East MULTIARM guides users through the complexities of multiplicity adjustment in order to construct reliable trials with multiple arms. A crucial regulatory requirement for multi-arm trials is establishing strong control of the family-wise error rate. East provides a variety of multiplicity adjustment measures to confirm strong control, along with advanced calculations that demonstrate a trial’s statistical power.

• Continuous endpoint: Difference of means
• Binary endpoint: Difference on proportions

Parametric Multiple Comparison Procedures:

• Dunnett’s single step
• Dunnett's step down
• Dunnett's step up

P-value based Multiple Comparison Procedures:

• Bonferroni
• Sidak
• Weighted Bonferroni
• Holm's step down
• Hochberg's step up
• Hommel's step up
• Fixed Sequence
• Fallback

View software license agreement here:

www.cytel.com/software-solutions/east/terms

East 6.5 Module: Predict

$ 708.00

This annual license fee is for a single designated desktop digital download license.

Academic pricing.

Requirements - Purchase of East Base and Sequential

PREDICT is an East module that offers the ability to simulate and forecast the future course of a trial based on current data. It includes conditional simulations to assess expected treatment effects and associated repeated confidence intervals at future looks (also called Predicted Interval Plots or PIP; Li et al. 2009), as well as the probability of finishing with a successful trial (conditional power). Plan and simulate clinical trials with greater precision using different accrual patterns and response information for different regions/sites. Make probabilistic statements about accruals, events, and study duration using Bayesian models and accumulating data.

View software license agreement here:

www.cytel.com/software-solutions/east/terms

East 6.5 Module: Sequential

$ 840.00

This annual license fee is for a single designated desktop digital download license.

Academic pricing.

Requirements - Purchase of East Base

SEQUENTIAL is an East module for planning, simulating, monitoring and communicating group sequential clinical trial designs. Provides a wide variety of options for normal and binomial endpoints in superiority, non-inferiority, and equivalence studies. Evaluate and compare the operating characteristics of different study designs on multiple information scales as well as graphically. Plan sample size, time, and cost savings by building in efficacy and futility boundaries. Quantify your trial’s probability of success while remaining sensitive to deviations both analytically and via simulation.

View software license agreement here:

www.cytel.com/software-solutions/east/terms

East 6.5 Module: SurvAdapt

$ 708.00

This annual license fee is for a single designated desktop digital download license.

Academic pricing.

Requirements - Purchase of East Base, Sequential and Survival

SURVADAPT is an East module for planning, simulating, monitoring, and communicating clinical trial designs that incorporate un-blinded sample size re-estimation rules. SURVADAPT provides a wide variety of options for survival endpoints, plus strong control of type-1 error rate. SURVADAPT includes hypothesis testing and adjusted inference based on methods by Cui, Hung, and Wang (1999), Mueller and Schafer (2001), Chen, DeMets, and Lan (2004), Gao, Ware and Mehta (2008), and the Promising Zone Design approach of Pocock and Mehta (2010). 

View software license agreement here:

www.cytel.com/software-solutions/east/terms

East 6.5 Module: Survival

$ 708.00

This annual license fee is for a single designated desktop digital download license.

Academic pricing.

Requirements - Purchase of East Base and Sequential

East SURVIVAL provides powerful yet simple to use simulation tools that can illustrate complex survival data at the design stage.

View software license agreement here:

www.cytel.com/software-solutions/east/terms

East 6.5 Module: MAMS

$ 708.00

This annual license fee is for a single designated desktop digital download license.

Academic pricing.

Requirements - Purchase of East BASE, MULTIARM, and SEQUENTIAL Modules

Multi-Arm Multi-Stage (MAMS) is an East module that offers the ability to design and monitor multi-arm multi-stage studies with options for early stopping, dose selection, and sample size re-estimation. It has two features: 

• The group sequential theory extended for multi-arm setup (Gao et al., 2014) has been implemented for normal endpoint.
• The multi-arm two-stage design using p-value combination approach (Posch et al., 2005) has been implemented for both normal and binomial endpoints.

East 6.5 Module: MCPMod

$ 708.00

This annual license fee is for a single designated desktop digital download license.

Academic pricing.

Requirements - Purchase of East Base Module

The European Medicines Agency (EMA) has qualified the Multiple Comparison Procedure – Modelling (MCP Mod) approach as an efficient statistical methodology for design and analysis of phase II dose finding studies under model uncertainty. East MCP Mod allows for the design and analysis of such studies for normal, binomial and count endpoints, with a variety of candidate models, dose selection criteria, and optimal allocations.

MCP Mod methodology is a combination of MCP (Multiple comparison procedures) and Mod (modeling) approaches (Bornkamp et al., 2009) for fitting a dose-response. This module allows you to design as well as analyze dose-response studies using MCP Mod.

Sample Size and Power Computation based on Optimal Allocation

East now offers users the ability to design dose-finding clinical trials using the MCP Mod methodology. Sample size and power computations can be done with user defined or optimized allocations.

Data Analysis using MCP Mod

East will accept raw subject data, summarized data or data with a covariance matrix for discrete and count data. In the case of continuous data, East only accepts raw data. East can perform multiple contrast tests to control Type I error, adjusting for the fact that multiple candidate dose-response models are being considered.

Features:

• Sample Size and Power Computation based on Optimal Allocation
• Data Analysis using MCP Mod
• Wide choice of candidate models
• Various model selection criteria
• Flexible dose estimation criteria
• Capability to incorporate data on covariates

Benefits

• Combines the two approaches – MCP and Modelling techniques
• More robust to model misspecification
• Flexible Target Dose estimation
• Control of Type-1 Error
• More informative phase 2 designs, more solid basis for confirmatory trials
• Endorsed by Regulators

Availability

Continuous, Discrete and Count Endpoint

East 6.5 Module: Enrich

$ 708.00

This annual license fee is for a single designated desktop digital download license.

Academic pricing.

Requirements - Purchase of East Base, Sequential and Survival Modules

East ENRICH supports the simulation of clinical trial designs with adaptation options for population enrichment, while strongly controlling type-1 error rate. It provides flexibility in defining the promising zone for sample size increase, and enrichment zone for subgroup selection.

Features - Population enrichment design for survival endpoint

East now offers users the ability to simulate a population enrichment design with a survival endpoint. This design starts out by enrolling subjects from a full population, which consists of a subpopulation of interest and its complement. East allows the user to perform an interim analysis and decide whether to continue enrolment in both subpopulations with or without sample size re-estimation, only continue enrolment from the subpopulation of interest, or terminate the trial for futility.

  Benefits

• Seamless phase 2/3 with Phase 2 objective to select the right patient population and Phase 3 to confirm the effect in the selected population
• Allows adaptation in sample size and patient population
• Mitigate risk of uncertainty around treatment effect and patient population
• Precision medicine to target the right treatment for the right patient population

   Availability

Survival Endpoint

East 6.5 Module: Program

$ 708.00

This annual license fee is for a single designated desktop digital download license.

Academic pricing.

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.

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

East Premium Bundle

$ 6,636.00

This annual license fee is for a single designated desktop digital download license.

Academic pricing.

Annual license includes all ten East Modules: Base, MultiArm, Sequential, Adapt, Survival, SurvAdapt, Exact, Endpoints, Predict and Escalate. See individual modules for further description.

View software license agreement here:

www.cytel.com/software-solutions/east/terms

East Ultimate Design Software Bundle

$ 7,716.00

This annual license fee is for a single designated desktop digital download license.

Academic pricing.

Includes all ten Modules for East:

BASE, MULTIARM, SEQUENTIAL, ADAPT, SURVIVAL, SURVADAPT, EXACT, ESCALATE, ENDPOINTS and PREDICT. 

Also includes Compass.

See detailed description under each separate module.

View software license agreement here:

www.cytel.com/software-solutions/east/terms