East Trial Design Software
East 6.4 Base
$ 255.00
This annual license fee is for a single designated desktop digital download license.
- Rapidly simulate and compare a wide variety of fixed sample trial options
- Accurately calculate required sample sizes across a variety of power levels
- Construct and assess superiority, non-inferiority, equivalence, and confidence-based designs
- Rapidly import and analyze clinical study data with on-board tools
- Run R scripts
View software license agreement here:
www.cytel.com/software-solutions/east/terms
East 6.4 Module: Adapt
$ 575.00
This annual license fee is for a single designated desktop digital download license.
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
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Adapt trials based on look, number, interim sample size, or information scale
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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.
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Experiment with multiple adaptation rules and select the best for your trial.
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Vary accrual and dropout patterns to perform sensitivity analysis.
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Fine-tune the design by comparing multiple values of all these parameters.
Conditional Power Calculators
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Accurate analysis at design and interim stage.
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Useful for early-stopping decisions.
Trial Simulation Tools
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Evaluate power and expected sample size of Cui, Hung and Wang method (Biometrics, 1999)
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Evaluate power and expected sample size of Chen, DeMets and Lan extension (Statistics in Medicine, 2004)
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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
East 6.4 Module: Endpoints
$ 200.00
This annual license fee is for a single designated desktop digital download license.
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 6.4 Module: Escalate
$ 650.00
This annual license fee is for a single designated desktop digital download license.
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
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East 6.4 Module: Exact
$ 200.00
This annual license fee is for a single designated desktop digital download license.
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 6.4 Module: Multi-Arm
$ 80.00
This annual license fee is for a single designated desktop digital download license.
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 6.4 Module: Predict
$ 650.00
This annual license fee is for a single designated desktop digital download license.
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 6.4 Module: Sequential
$ 765.00
This annual license fee is for a single designated desktop digital download license.
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 6.4 Module: SurvAdapt
$ 1,325.00
This annual license fee is for a single designated desktop digital download license.
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 6.4 Module: Survival
$ 575.00
This annual license fee is for a single designated desktop digital download license.
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.
- Non-uniform accrual
- Variable subject drop-outs
- Variable and fixed subject follow-up
- Piecewise exponential hazard rates
- Lagged treatment effects and other non-proportional hazards scenarios
- Option to specify accrual & study duration or accrual rate & sample size
- Multiple survival and drop-out parameter input methods
- Interactive event rate charts to predict accrual and accumulation of events over time
- Power charts based on sample size, accrual duration, study duration and number of events
- Stratified sampling and stratified Logrank Test
View software license agreement here:
www.cytel.com/software-solutions/east/terms
East 6.4 Base: MAMS
$ 650.00
This annual license fee is for a single designated desktop digital download license.
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 Premium Bundle
$ 5,036.25
This annual license fee is for a single designated desktop digital download license.
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
$ 6,175.25
This annual license fee is for a single designated desktop digital download license.
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
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