Cytel Signs Cooperative Research And Development Agreement With FDA Center for Devices and Radiological Hea...( Adaptive trials leader and CDRH regul...),Health

Adaptive trials leader and CDRH regulators join to create Bayesian trial design and analysis software standard

CAMBRIDGE, Mass., June 22 /PRNewswire/ -- Cytel Inc., a leading provider of biostatistical software and clinical trial design services, today announced the signing of a Cooperative Research And Development Agreement (CRADA) with the Center for Devices and Radiological Health (CDRH), a division of the United States Food and Drug Administration (FDA).

The agreement acknowledges that despite the CDRH's encouragement of clinical study sponsors to employ Bayesian-based device trials, no validated, easy-to-use design or analysis software has emerged. The goal of the CDRH collaboration with Cytel is to eliminate the productivity-sapping cycles of developing and validating ad-hoc methodologies with a reliable and easily-learned standard software package for both trial sponsors and regulators.

Gerry W. Gray, Ph.D., is the Principal Investigator for the FDA. Nitin Patel, Ph.D., Cytel Co-Founder, Chairman, and Chief Technology Officer, will lead the development effort as Cytel Principal Investigator.

Dr. Patel commented, "We are honored that CDRH chose Cytel as their partner for developing validated, documented, and commercially available Bayesian software. The CRADA is completely aligned with our vision of implementing innovative device and drug development approaches by combining high-quality software and knowledge-intensive services. Creation of these best-in-class Bayesian tools is a cru
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