The FDA’s recently issued adaptive trial guidelines draft encourages adaptive design use, especially in attempts to identify the optimal dose level.
Cytel has been at the forefront of applying adaptive trials in clinical practice for several years. Compass® has been developed from this experience and knowledge gained by East®, the extensively used adaptive and group sequential software for registration studies. Compass® now extends Cytel's adaptive design software line to include phase 2 dose-finding clinical trials.
Designers of dose ranging studies are challenged to find the correct dose(s) to carry into confirmatory development. The PhRMA Adaptive Dose Response Group has shown that adaptive methods often substantially improve on traditional designs at this crucial best dose determination stage.
Wider use of adaptive trials at this stage was previously inhibited by the lack of validated commercial software. Sponsor statisticians and their regulatory counterparts could only attempt to write their own statistical design code.
The advent of Compass® provides study planners with a workflow for modern dose identification study construction using accepted adaptive methods. The built-in high-speed simulation engine quantifies design option decision-making, while visualizations of the trial characteristics improve understanding amongst both development teams and regulators, too.
A demonstration is replay-able at: http://www.cytel.com/News/Webinars.aspx
Of the release milestone, Compass® Product Manager, Yannis Jemiai, Ph.D., said: "We're very proud of our collective work to place modern, industrial strength adaptive design tools in the hands of the drug developers engaged in dose-finding clinical research. Compass® users will more easily choose the best options and conduct successful adaptive trials. Our trial simulations implementation is based on techniques proven to help sponsors to make knowledgeable decisions time and time again."
About Cytel Inc.
47 of the top 50 biopharmaceutical firms use Cytel software to design, simulate and analyze their clinical studies. Cytel serves trial sponsors with innovative tools, training and consultation to increase clinical development efficiencies and success rates.
SOURCE Cytel Inc.
