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A clinical trial design is the blueprint for its eventual success.

Where are we today?

East is the industry standard for designing adequate and well-controlled clinical trials

EMPOWER

Play a more strategic role in your organization.

East simplifies and automates study design and simulation, freeing more of your time to contribute in greater ways to the success of your trial or program.

Quickly create multiple designs at once

Add accrual, response lag, and dropout for normal and binomial endpoints

Disable efficacy or futility boundaries at selected interim looks

Preview, sort, and filter a large set of designs before saving

ASSESS

Rapidly generate multiple fixed, group sequential, and adaptive designs.

Easily evaluate the robustness of your design to critical assumptions by performing sensitivity analysis. Use tables and graphs to compare operating characteristics of different approaches

Compare trials of different types and different endpoints

Multiple comparison procedures for multi-arm pairwise comparisons to control

Powerful simulation engine for sensitivity analysis and prediction

SHARE

Communicate the merits of various trial design options to your project team.

With the help of readily understood graphs, tables, flexible reporting, and powerful simulation capabilities, share design properties in real time.

Visualize multiple designs on a single chart

Customizable charts and tables to enhance communication with stakeholders

Flexible options for survival designs

TRUST

Depend on East, knowing it has been fully validated and intensely tested.

East-generated designs have been relied upon for more than 20 years in countless actual studies at all the major pharmaceutical and biotech companies.

Detailed output for designs

Convenient trial monitoring dashboard to analyze interim data and facilitate decision-making

Negative Symptoms Schizophrenia

New drug versus placebo for treatment of negative symptoms of schizophrenia

Primary endpoint: change in negative symptoms assessment (NSA) at week 26 relative to baseline

Detect a 2-point improvement (δ = 2, σ = 7.5) in NSA

The smallest clinically important effect is δ = 1.6

Breast Cancer

Femara vs. Tamoxifen adjuvant (FEMTA) trial was launched in March 1998

Two-arm head to head comparison for post-menopausal women with operable breast cancer

Primary endpoint: disease free survival (DFS)

75% 5-year DFS for Tamoxifen. Desire 80% power to detect HR = 0.8065

Design a 5-year study, with 3 years of enrollment and 2 years of follow-up

“IF#YOU#DO#NOT#KNOW#HOW#TO#ASK#THE#RIGHT#QUESTION,#YOU#DISCOVER#NOTHING”##

W.#Edwards#Deming!!

Thank you