CAMBRIDGE, Mass.--(BUSINESS WIRE)--Cytel Inc., a global provider of adaptive trial design software, statistical consultancy, and clinical research services, today announced the release of East® version 6.4. East®, the life science industry’s leading clinical trial design platform, will deliver expanded functionality to support the application of groundbreaking methods including multi-arm multi-stage designs, and dual agent dose escalation designs for combination therapies. With ever-increasing pressure on the industry to improve R&D productivity and reduce Phase 3 failure rates, uptake of adaptive designs is set to rise . The innovative designs incorporated in the 6.4 release address key pain points of sponsors and researchers looking to apply advanced statistical strategies with potential to accelerate development.
“Our goal is to enable the implementation of cutting-edge, published statistical methods and ultimately increase our customers’ chances of success in clinical development," said Yannis Jemiai, Ph.D., Vice President of Cytel. “Statisticians rely on East® to simplify the application of complex approaches, within a trusted, validated environment. The East® 6.4 release represents our commitment to meeting the evolving needs of our clients, and is the result of extensive work by our software development team as well as ongoing collaboration with industry sponsors and academic researchers.”
The enhanced capabilities span three modules:
There is increasing interest in designing multi-arm multi-stage trials with treatment selection and sample size re-estimation at interim analysis. This brand new module in East® facilitates the design, simulation and monitoring of such trials in a streamlined manner, using group sequential, p-value combination, and closed testing principle approaches to strongly control the type 1 error (false positive rate).
This popular module for design, simulation, and analysis of Phase 1 dose escalation trials has been upgraded to support recognized dual agent dose escalation designs, with the incorporation of the Bayesian logistic regression model (BLRM) for two agents, and the Product of Independent beta Probabilities dose Escalation (PIPE) method.
Accurate prediction of the rate of patient enrollment and the accumulation of events is critical for clinical trial planning. The upgraded East® PREDICT module in 6.4 now has the functionality to predict future events, enrollment and study duration using blinded as well as unblinded data.
East® 6.4 is the industry standard platform for clinical trial design, simulation, and monitoring. East improves scientific productivity during the critical planning stages of clinical development, by providing a comprehensive design environment that implements adaptive designs in line with guidance from health authorities. Efficient workflows and high-quality outputs reduce barriers to learning and collaboration to enable more impactful quantitative decision making. More information about East® is available at www.cytel.com
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"Tufts CSDD Report: Drugmakers Modifying R&D To Temper Health Care Costs While Upping Productivity - MedCity News". MedCity News. N.p., 2015. Web. 12 May 2016.