2. A clinical trial design is the blueprint for its
eventual success.
3. Where are we today?
East is the industry standard
for designing adequate and
well-controlled clinical trials
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7. 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.
8. 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
9. 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
10. 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
11. 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.
12. Visualize multiple designs on a single chart
Customizable charts and tables to enhance
communication with stakeholders
Flexible options for survival designs
13. 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.
14. Detailed output for designs
Convenient trial monitoring dashboard to analyze
interim data and facilitate decision-making
15. 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
16. 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
