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Bayesian Clinical Trial Designs
Discover the power of Bayesian clinical trial designs with Cytel. Our expertise and innovative methods ensure flexible, data-driven solutions for your clinical trials, making advanced statistical techniques accessible.
Our Bayesian Trial Design Services
Bayesian methods are a form of statistical analysis where a hypothesis called a prior is systematically updated as more data comes in. This makes Bayesian methods ideal for small sample trials, clinical trials using historical data and real-world solutions, or clinical trials that require flexible learning. These computationally intensive statistical methods were once only accessible to a small number of specialized statisticians working in the top 20 pharmaceutical companies. For over a decade, statisticians at Cytel have been committed to ensuring that clinical solutions requiring Bayesian statistics are made accessible to all who need them.
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Features and Benefits
Cytel scientists are at the forefront of Bayesian innovation. They have taken a lead in developing:
- Early phase dose-finding methods including Hi3+3
- Uses of meta-analytics priors in clinical trial design
- The use of synthetic and external control arms, and complex statistical designs such as basket and umbrella trials
- New methods for real–world evidence such as quantitative bias analysis
When Do You Need Bayesian Methods?
Bayesian methods are used as solutions for a wide variety of clinical trial challenges. The adoption of historical and external data into a clinical trial to supplement regulatory submissions is a growing use of Bayesian methods. Similarly, in therapeutic areas like oncology where the standard of care might evolve during a clinical trial, statisticians trained in Bayesian methods can help salvage data collected during the trial.
The nature of statistics is such that many common problems can be solved using both Frequentist or Bayesian methods but with different time investments and resources, depending on the situation. Cytel’s consulting and RWE teams are trained in the traditional Frequentist paradigm and Bayesian solutions for a vast range of scenarios.
At Cytel we believe that statisticians should be well-versed in both Bayesian and Frequentist statistical paradigms so that they can apply the best solutions for your specific needs. Our hybrid approach ensures that you receive tailored solutions that build on the best of both paradigms.
Bayesian Clinical Trial Design
Software: Cytel provides both software and services to guide you through the design of the perfect Bayesian clinical trial. Our East Horizon Platform for clinical trial design provides validated software that enables all statisticians to consider Bayesian tools. We also equip statisticians with rigorously tested tools for complex Bayesian innovations, many of which are innovations first published by Cytel scientists.
Statistical Consulting: Our expert statistical consultants have experience designing Bayesian clinical trials from early phase to regulatory submission, even designing basket trials, synthetic control arms and other complex innovative trial designs. Their designs are supported by insights from premier network meta-analyses.
Cytel statistical consultants can help you:
- Build approaches for flexible learning into your clinical trial.
- Assimilate historical, real-world or other forms of external data into your clinical trial.
- Strengthen your Phase III regulatory submission with the addition of external data (i.e. utilize a variety of hybrid methods).
- Determine how to incorporate model-based and other modern modes of dose-finding.
- Build strategic elements like in-trial learning, resource management and other objectives into your design using Bayesian methods.
Employee Testimonial
Adaptive Bayesian techniques are the most natural way of including historical and in-trial data to inform and adapt the course of the trial and provide a more intuitive interpretation of the results. Adaptive trials use Bayesian techniques because they enable considered in-trial changes.
Dr. Kyle Wathen
VP of Scientific Strategy and Innovation
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