$ 276.00
View software license agreement here:
www.cytel.com/software-solutions/east/terms
$ 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).
Sample Size Re-estimation
Adapt trials based on look, number, interim sample size, or information scale
Define the Promising Zone based on conditional power, test statistic, or estimated effect size. The Promising Zone allows users to determine increases in sample size given information acquired during the trial.
Experiment with multiple adaptation rules and select the best for your trial.
Vary accrual and dropout patterns to perform sensitivity analysis.
Fine-tune the design by comparing multiple values of all these parameters.
Conditional Power Calculators
Accurate analysis at design and interim stage.
Useful for early-stopping decisions.
Trial Simulation Tools
Evaluate power and expected sample size of Cui, Hung and Wang method (Biometrics, 1999)
Evaluate power and expected sample size of Chen, DeMets and Lan extension (Statistics in Medicine, 2004)
Evaluate power and expected sample size of Müller and Schäfer method (Biometrics, 2001)
View software license agreement here:
http://www.cytel.com/software-solutions/east/terms
$ 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
$ 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
View full product details$ 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
$ 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.
Parametric Multiple Comparison Procedures:
P-value based Multiple Comparison Procedures:
View software license agreement here:
www.cytel.com/software-solutions/east/terms
$ 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
$ 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
$ 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
$ 708.00
This annual license fee is for a single designated desktop digital download license.
Academic pricing.
Requirements - Purchase of East Base and Sequential
SURVIVAL is an East module for planning, simulating, monitoring and communicating group sequential clinical trial designs with survival endpoints. SURVIVAL provides a wide variety of options for survival endpoints in superiority and non-inferiority studies. It includes advanced capabilities to account for subject dropouts, non-uniform accrual, non-constant hazard rates and fixed follow-up time in studies with time-to-event endpoints. Simulate for accurate estimation of the total study duration - even under different enrollment patterns with differential drop out and varying hazard rates for the treatment arms, or to accommodate alternatives for non-proportional hazards.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
$ 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:
$ 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:
Benefits
Availability
Continuous, Discrete and Count Endpoint
$ 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
Availability
Survival Endpoint
View full product details$ 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
Benefits
Availability
Continuous, Discrete and Survival Endpoints
View full product details$ 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
$ 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