East® 6

The Comprehensive Trial Design Solution

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Extensive time and energy is often spent designing feasible clinical studies. East's broad range of statistical tools and expert simulations provides an invaluable resource for the rapid construction of trial designs. Illuminating graphs and charts allow for accessible comparison, while a user-friendly interface encourages exploration and experiment.

East® addresses the concerns and requirements in the FDA guidance
“Adaptive Design Clinical Trials for Drugs and Biologics."

East® 6.5 The Software Behind Your Next Successful Trial

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The Advantages of East

Developed by accomplished study design experts, East creates clinical trials that best address key questions confronted by clinical investigators. East is widely validated in practice and referred to by international regulatory agencies.

Powerful simulation tools allow users to compare designs and choose the trial best suited to their study's objectives. Intuitively organized tasks and workflows further enhance productivity. East provides opportunities to optimize the process of selecting superior designs, and ensures access to a range of proven algorithms.

Read the current FDA adaptive trial guidance

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 Empower Your Team

Play a more strategic role in your organization: East simplifies and automates study design and simulation, allowing users to redirect time, attention and critical resources to other vital aspectsof clinical trial success.

 Share Ideas Easily

Convince your team of the merits of your design: Powerful simulations and customizable tables, graphs and charts, facilitate clear communication with colleagues and authorities. Foster a collaborative environment for project teams by sharing designs in real time.

 Assess All Options

Optimize your trial design: Rapidly generate multiple adaptive designs, perform sensitivity analysis to evaluate their robustness to critical assumptions, and use sophisticated tables and graphs to compare their operating characteristics.

 Trusted Results

Be confident you have the right design: Trusted and validated for over 25 years, East has been used to design countless clinical trials performed in industry, government, and academia. Regulatory authorities throughout the world trust East.

The Modular Format Start with the East BASE and add additional modules when you need them.

* New Modules

  • East

East BASE

East BASE is a user friendly, validated software package for planning, simulating, analyzing and communicating fixed-sample clinical trial designs. East BASE provides a wide variety of options for Normal, Binomial, and Survival endpoints, with advanced capabilities for complex patterns of accruals, dropouts and response lag. It includes superiority, non-inferiority, equivalence, and confidence-interval based designs.

East MULTIARM

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.

East Sequential

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.

East ENDPOINTS

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.

East Exact

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.

East Escalate

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; 2015), the modified Toxicity Probability Interval (mTPI; Ji et al., 2010), and the Product of Independent Beta Probabilities Escalation method (PIPE; Mander & Sweeting, 2015).

MCPmod *

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 MCPMOD 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.

Program *

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.

MAMS

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 Survival

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.

East Adapt

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).

East Predict

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 accumulating data.

PROCs

East® PROCs is a new tool for SAS users, which allows programmers to access the East® Interim Monitoring Dashboard within a SAS interface. SAS users can now design and monitor group sequential trials, and conduct sample-size re-estimation. Results from East® PROCs are easy to import back to East® for interactive decision-making and simulations.

East SurvAdapt

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).

Enrich *

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.

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The Features of East

 

Sample size and power calculations

Compute the ideal number of subjects for every trial using advanced methods for sample size and power calculations. A broad array of design options addresses your trial’s key objectives.

Trial Monitoring Dashboard

Use simple trial monitoring tools for effective interim data analysis and decision-making. Provide expert support to the data monitoring committee by predicting the timing of interim analyses, the trial’s probability of success, and other essential information.

Documentation and Support

Text-book quality manuals and a world-renowned set of statistical experts provide technical support and advanced consulting services.

Adaptive features planning

Compare and fine-tune your trial’s adaptation rules by running simulations under multiple scenarios. Adaptive design features, based on proven and published methods, increase your trial’s chances of success.

Advanced simulations

Investigate and test hypotheses in silico prior to costly experimental implementation. Powerful simulation engines illustrate potential trial outcomes for simplified design assessment and comparison.

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The Software Behind Your Next Successful Trial