Berry Consultants, LLC today announced that FACTS 7 has been released to current users and is now available to all new customers. FACTS (Fixed and Adaptive Clinical Trial Simulator) is the most powerful, flexible and fastest simulation tool on the market for advanced clinical trial design. FACTS covers the full spectrum of trial designs, from early development Phase I trials to innovative Phase II trials and efficient Phase III projects. With the release of FACTS 7 and the new platform testing module, FACTS becomes the first commercially available and validated software for the design and simulation of adaptive platform testing.
The team at Berry Consultants is an internationally renowned leader in the creation, design and implementation of platform assays in many disease areas such as ALS, breast cancer, Alzheimer’s, pancreatic cancer, glioblastoma multiforme, influenza, pneumonia and COVID-19. currently expanding platform trials into many other disease areas for sponsors. These platform trials are created with a master protocol to allow multiple therapies to be investigated in a single trial, being added continuously, all with shared infrastructure. In addition, a platform trial allows multiple arms to share common control, share common trial infrastructure, and allows for better treatment of patients in the trial. The concept of platform trials is a win-win with smaller sample sizes, reduced patients on placebo, lower costs, reduced timelines, and better inferences for regulators. Now with FACTS 7, this innovative platform testing approach can be shared with commercial customers by licensing the FACTS software suite.
Scott Berry, PhD, President and Senior Statistical Scientist at Berry Consultants, said, “This is an exciting day for our FACTS software and all of its users. This new design and software release module transforms FACTS to allow users to build efficient adaptive platform testing. There are so many advantages to platform testing and now FACTS allows for full and efficient simulation to optimize these tests.”
This FACTS 7 Platform Trials starter module allows users to simulate trials where many treatments are tested, with treatments entering and leaving the trial over time. Its current simulation capabilities are for continuous and dichotomous final stages with multiple trial-level participants and branch constraints. In particular, users can specify a maximum enrollment time, number of participants, definition of successful treatments, participants per branch and concurrent treatments. In addition, it has the ability to simulate treatments arriving at different times during the trial and offer allocation options that include fixed ratio to control, allocation rates as a function of the number of treatments, and adaptive response randomization.
Tom Parke, Director of Software Solutions at Berry Consultants added, “We are excited to be able to extract some of the platform testing concepts and approaches from the scientific team at Berry Consultants and apply them to our FACTS software. This new module brings some initial features and functions to our FACTS users as a first step, and we will continue to develop this platform testing software in future releases. We will continue to develop FACTS and provide our users with the latest and most innovative resources in clinical trial design.”
With this release, FACTS continues to share a common framework, platform and philosophy: clinical trial simulation should be easy to set up, flexible, quick to run and clear in its results. FACTS allows users to specify tests across the spectrum, from the simplest and most widely used to the most innovative.
About Berry Consultants
Berry Consultants is a statistical consulting firm specializing in innovative clinical trial design, analysis, execution, and software solutions for the pharmaceutical and medical device industry. We employ world-renowned experts in Bayesian statistics and strive to set the standard for adaptive clinical trial design and analysis across all medical disciplines. www.berryconsultants.com
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Contact:
Berry Consultants
(512) 213-6428
[email protected]
Source: BUSINESS WIRE