AUSTIN, TEXAS-- April 13, 2023 -- Berry Consultants, LLC announced today that FACTS 7 was released to existing users and is now available to all new clients. 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 whole spectrum of trial designs, from early development phase I trials, to innovative phase II trials, and efficient phase III designs. With the release of FACTS 7 and the new platform trial module, FACTS becomes the first commercially available and validated software for the design and simulation of adaptive platform trials.

The Berry Consultants team is the internationally renowned leader in the creation, design, and implementation of platform trials in many disease areas such as ALS, Breast Cancer, Alzheimer’s, Pancreatic Cancer, Glioblastoma Multiforme, Influenza, Pneumonia, and COVID-19, and is currently expanding platform trials into many more disease areas for sponsors. These platform trials are built 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 a common control, share the common infrastructure of the trial, and it allows the better treatment of patients in the trial. The platform trial concept is a win-win for all stakeholders - smaller sample size, reduced patients on placebo, reduced costs, reduced timelines, and better inferences for regulators. Now with FACTS 7, this innovative approach of platform trials can be shared to commercial clients through licensing the FACTS software package.

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 module and software release transforms FACTS to allow users to design an efficient adaptive platform trial. There are so many advantages of platform trials and now FACTS allows for thorough and efficient simulation for optimizing these trials.”

This initial platform trial module of FACTS 7 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 endpoints with various trial level participant and arm constraints. In particular, users can specify a maximum enrollment time, number of participants, definition of successful treatments, participants per arm and concurrent treatments. In addition, it has the capability to simulate treatments arriving at different times during the trial and provide allocation options that include fixed proportion to control, allocation ratios dependent on the number of treatments and response adaptive randomization.

Tom Parke, Director of Software Solutions of Berry Consultants, added, "We are thrilled to be able to take some of the concepts and approaches of platform trials from the Berry Consultants scientific team and be able to apply that to our FACTS software. This new module brings some initial capabilities and features to our FACTS users as a first step, and we will be continuing to develop this platform trial software in future releases. We will continue to develop FACTS and provide to our users the latest and most innovative features in clinical trial design.”

With this release, FACTS continues to share a common structure, platform and philosophy: that simulation of clinical trials should be easy to set up, flexible, fast to run, and clear in their outcomes. FACTS allows users to specify trials across the whole spectrum from the simplest and widely used to the most innovative.