Comprehensive Clinical Trial Design Capabilities

FACTS features dedicated engines for key trial types, supporting the most critical elements of clinical trial design, including:

• Dose Escalation Trials: Model dose tolerability and efficacy with a Bayesian CRM or find the maximum tolerated dose with a deterministic escalation strategy like mTPI.‍
• Dose Finding Trials: Model dose-response relationships and adaptively allocate to determine optimal dosing strategies for multi-arm Phase 2 trials.‍
• Adaptive Phase 3 Trials: Design adaptive pivotal trials with early stopping for success and futility based on frequentist or Bayesian quantities.
• Seamless Phase 2/3 Designs: Design a phase 2 dose finding trial that seamlessly morphs to a phase 3 study at an interim analysis. Add complexity wherever you would like it with separate tailored adaptations in each phase.‍
• Platform Trials: Design and simulate an adaptive platform trial with a shared control arm which treatments can continuously enter and leave.‍
• Multiple Endpoint Trials: Simulation multiple endpoints per subject and design an adaptive trial intended to optimize your specified utility function.‍
• Enrichment Designs: Target specific subpopulations and adaptively modify the enrolling population to maximize trial efficiency and impact..

These engines empower teams to test design decisions before trials begin, allowing them to refine approaches, reduce risk, and maximize efficiency. By running thousands of simulations, teams can see how different trial elements impact outcomes, identify the most effective strategies, and build more efficient, effective trials.

The Power of Clinical Trial Simulation

Clinical trial simulation is the future of trial design - and FACTS leads the way. Without simulations, trial planning relies on narrow assumptions with limited visibility into how a trial will perform. FACTS eliminates this uncertainty by enabling comprehensive scenario testing on an enormous range of adaptations, helping teams understand more than just the probability of success across a range of possible outcomes. Simulation capabilities of the core engine alone include:



Flexible Virtual Subject Simulation:

• Subject Accrual Rate: Choose a simple fixed accrual rate, or add and remove sites from the accrual profile with ramp up and down accrual rate at each site.
• Subject Discontinuation: Simulate subjects lost to follow up per dose, and with varied rate over follow-up time.
• Endpoint Options: Simulate a continuous, dichotomous, or time-to-event endpoint, or simulate and model up to 4 continuous/dichotomous endpoints per subject and make decisions based on a utility function.
• Treatment Effectiveness Assumptions: Simulate the design under many different primary endpoint assumptions, or upload subject outcomes from an external file for a completely custom profile.
• Longitudinal Patient Data: Simulate multiple visits per virtual subject, and specify the correlation between early visits and the final visit. All longitudinal profiles can be crossed with any FACTS specified treatment effectiveness assumptions.

Design Adaptations:

• Interim Analyses: Trigger interim analyses as a function of time, subjects enrolled, complete, or with the opportunity to complete follow-up. Create different decision rules at each interim analysis.
• Decision Making Quantities: Make interim or final analysis decisions based on posterior probability, predictive probability, conditional power, p-values, probability of non-inferiority/super superiority, probability of being the ED90, probability of being the minimum effective dose, and many more quantities.
• Adaptive Allocation: Improve trial power and treat subjects better by using response adaptive randomization or arm dropping to preferentially randomize subjects to better performing treatments.‍
• Dose-response Modeling: Model the relationship between study arms with more than 10 Bayesian dose response models including hierarchical models, Normal Dynamic Linear Models, U-shaped models, and more.‍
• Multiple Imputation: Utilize model based multiple imputation in Bayesian models to leverage data from subjects with only early data. Use all of the information available to you!
  Historical Borrowing: Use past study results to construct a hierarchical prior for the control arm.

In addition, other engines add different adaptation opportunities:

• Enrichment Designs: Model treatment effectiveness by subtype in a hierarchical model and adaptively made early stopping decisions or enrich the enrolling population.
• Staged Designs: Make adaptive go/no-go decisions and specify decision rules to dynamically determine which arms from Phase 2 should be included in the Phase 3 stage. Each stage is fully flexible and has all of the core adaptations listed above available.
• Platform Trials: Allow treatment arms to begin randomizing in a platform trial at probabilistic times, simulate arm effectiveness from a distribution, and make decisions on those arms based on all patients or concurrent controls. Adaptively allocate subjects to currently enrolling arms, and estimate Bayesian or frequentist quantities to make decisions.‍
• Dose Escalation Designs: Use a simple mTPI design, or fit a Bayesian logistic regression model and specify escalation rules with a CRM. Include efficacy in the escalation model and decisions, or add 2-dimensional dosing with joint modelling of the DLT rates across dosing dimensions. Specify explicit parametric safety profiles to assess your design across many different potential scenarios.

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Why FACTS Stands Out

FACTS isn't just another simulation tool -- it's a fully supported, commercial-grade software system that puts statistics at the forefront. Here's why it stands out on the market:

• Step-by-step design process: Easily build, test, and iterate on fixed and adaptive trial designs.
• Statistics first approach: Utilize advanced statistical concepts with confidence through software developed by statisticians.
• Cost and time savings: Identify optimal trial designs that reduce development costs and shorten timelines.
• Simulation-driven decisions: Assess designs in minutes through built in visualizations, or export simulation data and create bespoke tables and graphics on your own.
• Faster trial development: Reduce time to launch with seamless, iterative design processes.
• Simulation Speed: When simulating thousands of trials, computational speed is crucial. FACTS is built on a C++ platform enabling grid based parallelization and is the fastest simulator in the industry.
• Fast, Customer Support: The FACTS help desk is manned by its developers. Receive responses to your questions from real developers, and real statisticians.

Designed for Every Trial Phase

From Phase 1 to Phase 4 including seamless trials, or designing a platform trial with multiple treatments — FACTS provides the clarity, speed, and precision required to design Innovative, faster trials. With FACTS, you can harness the power of adaptive trial simulation to:


• Shorten timelines for trial design, development, and regulatory submissions.
• Reduce costs by optimizing trial size, design, and key parameters.
• Improve decision-making with data-driven insights that increase the likelihood of trial success.