AUSTIN, Texas--(BUSINESS WIRE)--Berry Consultants, LLC announced today that FACTS 5 was released to existing users earlier this month, 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 FACTS 5, the simulator becomes considerably more flexible with a richer set of analyses and design features.
Tom Parke, Director of Software Solutions of Berry Consultants, said, "It is the way that FACTS allows a user to gradually evolve a design from simpler to more complicated that gives it its incredible power. All the design options interoperate with each other, allowing designs of great sophistication to be created, but the options can be introduced one at time, ensuring the designer is always in control and able to gauge the impact and worth of each design feature independently."
FACTS 5 increases the range of phase II trials that can be designed. FACTS 5 allows the simulation of complex dose-finding trials, including utilizing dose-response modeling, and innovative adaptive features. Additionally FACTS allows Phase II or III personalized medicine trials to be designed. Basket trials, where the relative efficacy of the treatment may depend on the characteristics of the patient, are becoming increasingly important and FACTS now has increased functionality for designing these types of trials.
FACTS 5 allows a full range of Bayesian and frequentist analyses to be included in the trial design. Users can now specify any number or form of Quantities of Interest (QOIs) to be calculated. These flexible QOIs can compare any specific arm, against any other arm, and with any delta and be used to drive the results or adaptations in the trial. In addition, FACTS 5 allows the designer more flexibility in the structure, timing, and actions at each interim analysis. This increased control allows incredibly flexible designs to be simulated.
FACTS 5 now includes the calculation of Bayesian predictive probabilities for use in designs. Predictive probabilities can be used for futility analyses or for sample size selection. Predictive probabilities are a natural and very powerful way to frame interim decisions. These quantities allow, for instance, a trial to be stopped for futility if the predictive probability of success at the end of the trial is less than 1% or for accrual to be stopped and the existing subjects followed to completion if the predictive probability of success of so doing is at least 99%. Two of the barriers to using predictive probabilities have been the complexity of programming required and the huge additional computer time required to compute them within thousands of simulation runs. The highly efficient implementation of predictive probabilities within FACTS brings them within the reach of every trial designer.
With this release, FACTS continues to share a common structure, platform and philosophy: that simulation of clinical trials should be easy to setup, 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.
For more product and sales information about FACTS, contact: FACTS@BerryConsultants.com
About Berry Consultants
Berry Consultants is a statistical consulting company specializing in innovative clinical trial design, analysis, execution, and software solutions for the pharmaceutical and medical device industry. www.berryconsultants.com
