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 crucial initiative in our efforts to help the clinical development community to reduce time-to-market, cut costs, and improve portfolio returns."
The CRADA Research Plan Abstract
The Center for Devices and Radiological Health (CDRH) at the FDA encourages sponsors to use innovative Bayesian designs for clinical trials involving device products. The Bayesian approach provides a natural way to combine prior evidence with current data. Moreover for devices, good prior information often exists, as for example in studies of previous generations of the same device. At the present time the software tools that are needed for designing and analyzing Bayesian clinical trials are not available in any validated, commercially viable, easy to use software package. Thus, execution of Bayesian clinical trials requires considerable expertise in both Bayesian methodology and in computer programming.
Further, CDRH statisticians usually need to write special programs to verify the operating characteristics of each Bayesian submission separately. This is an inhibiting factor and puts considerable burden on sponsors in carrying out the simulations that are submitted to CDRH and on CDRH statisticians in validating what is submitted.
Cytel Inc. is a leading provider of specialized statistical software and clinical trial services for the biopharmaceutical, medical device, academic and government research markets.
Cytel pioneered the statistical and computational science of adaptive clinical trials and has designed more validated adaptive trials than any other service provider. Cytel serves trial sponsors with innovative tools, training and consultation to increase the return on investment in clinical development.
CONTACT: Michael Weitz, Director of Marketing of Cytel Inc.,
Web site: http://www.cytel.com/