East Horizon™ Platform: Uniting East_® and Solara_® for Enhanced Trial Design

Introducing East Horizon Platform’s Comprehensive Modules

1. Early Stage: Dose Escalation – Tailored tools for optimizing Phase I dose escalation studies, facilitating safe and efficient determination of optimal dosing levels. It allows for better characterization of Maximum Tolerated Dose (MTD) while improving screening and selection of active arms to carry forward. The methods include: 3+3, Continual Reassessment Method (CRM), Bayesian Logistic Regression Model (BLRM), and modified Toxicity Probability Interval (mTPI).
2. Early Stage: Dose Finding – Enables precise determination of optimal dosage levels in early-stage trials, streamlining the dose-finding process for improved efficacy and safety by leveraging both Frequentist and Bayesian approaches. It allows the generation of response data through dose-response modeling with the flexibility of a wide range of targets: absolute difference, difference from placebo, quantiles of dose response curve, best dose, etc. The methods include: T-test- based up and down with 1 or 2 targets, maximizing designs, four parameter logistic, Emax, and Normal Dynamic Linear model.
   
3. Late Stage: Fixed Sample – Equips users with essential tools for designing fixed-sample clinical trials, providing a solid foundation for late-stage trial development with Frequentist, Bayesian, and Exact statistical methods for comparative and non-comparative studies. The endpoints include: continuous, binomial, negative binomial, and survival, including super-superiority designs.
4. Late Stage: Group Sequential – Facilitates seamless implementation of group sequential designs, enabling adaptive methods and stratification in a variety of endpoint types. There are extensive options for stopping rule families and boundary visualizations, as well as conditional and predictive power calculations for interim decisions.
5. Late Stage: Multiplicity – Provides specialized tools for managing multiplicity of both endpoints and study arms in clinical trials, ensuring robust control over type I error rates in late-stage studies. The designs include: Multi-Arm Multi-Stage (MAMS) designs with treatment selection using the p-value combination method, as well as strategic testing of multiple endpoints. A variety of Multiplicity Comparison Procedures (MCPs) are available for selection.
6. Late Stage: Adaptive – Offers a range of adaptive design options for late-stage superiority and non-inferiority trials, allowing for dynamic sample size adjustments based on interim data analysis either through sample size re-estimation (SSR) methods or through promising subgroup population enrichment. The SSR methods include CHW, CDL and Müller-Schäfer.

Combined within East Horizon platform, these modules empower users to design and execute a wide range of clinical trials across all stages of development with precision and efficiency.