East Infosheet
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East is clinical trial design software that allows users to quickly generate multiple trial designs, assess their operating characteristics through simulation, and share designs with stakeholders through customizable reports and graphs. It has been extensively tested and validated, with designs relied upon for over 20 years in numerous pharmaceutical studies. The document provides two examples of clinical trial scenarios that could be modeled in East: a schizophrenia trial comparing a new drug to placebo on negative symptom outcomes, and an adjuvant breast cancer trial comparing Femara to Tamoxifen on disease-free survival.
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Adaptive clinical trials can reduce risks and costs for drug sponsors by allowing sample sizes to increase if interim results are promising. The East software allows users to efficiently design adaptive trials through simulations of different scenarios to determine optimal interim analysis points. It ensures strong control of type 1 error rates required by regulators while adaptively increasing power. Users can customize designs for normal, binomial, or survival endpoints based on interim data and sample size to optimally de-risk investments in late-stage trials.
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Adaptive clinical trials can help reduce risk for sponsors by allowing sample sizes to increase if initial treatment assumptions are incorrect. The document describes how the East software allows users to design adaptive trials that preserve statistical validity while enhancing success. East users can simulate different design scenarios to determine optimal interim analysis points and ensure type 1 error control as required by regulators. This helps de-risk investment and boost power if initial power calculations are insufficient.
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Statistical software has various applications in fields like medical research, education, business, healthcare, food science, and more. It helps analyze large amounts of data, draw reasonable inferences, and make accurate decisions. In medical research, statistical tools help handle data collection, organization, analysis and interpretation efficiently. In education, software like STATA and SPSS are used for statistical analysis and creating graphs in economics and other social science courses. Statistical software also helps analyze business data across departments to make informed decisions. It allows exploring relationships in clinical trials and quality of patient care in healthcare.
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SPSS is statistical software used for statistical analysis, data manipulation, and generating tables and graphs summarizing data. It performs basic descriptive statistics as well as advanced statistical techniques like regression, ANOVA, and factor analysis. SPSS allows importing and exporting data from different sources and connecting to online databases. It is robust, but training is typically required to fully utilize its features. SPSS is widely used in research and development, quality control, compliance and validation, clinical trials, and data mining in the pharmaceutical industry.
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East Infosheet
- 1. Powered by
- 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
- 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