Navigation Links
Cytel Signs Cooperative Research And Development Agreement With FDA Center for Devices and Radiological Health (CDRH)

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.

About Cytel

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.

SOURCE Cytel Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Cytels Clinical Innovation Experts Cyrus Mehta and Judith Quinlan Reveal Latest Adaptive Trial Successes at 44th Annual DIA Meeting
2. Judith Quinlan Joins Cytel as Vice President, Adaptive Trials
3. Cordex Signs European Development Partnership for ATPotent(TM) Sperm Motility Drug
4. Two-Year Data Show Patients Receiving SIMPONI(TM) (golimumab) Experienced Sustained Improvement in Signs and Symptoms of Psoriatic Arthritis and Ankylosing Spondylitis
5. VivoMetrics(R) Introduces Next Generation LifeShirt Prototype, a Smart Garment That Delivers Real-time Vital Signs Remotely to Healthcare Providers
6. Moffitt Cancer Center Signs Licensing Agreement with Frantz BioMarkers, LLC
7. Perceptive Informatics Survey Results Reveal Top Barriers to Implementing Adaptive Trial Designs
8. Optigenex Inc. Signs New License and Distribution Agreement With Itochu Corporation of Japan
9. MultiCell Technologies Signs Liver Stem Cell R&D Agreement To Develop Products for the Study of Liver Cancer
10. Cephalon Signs Option Agreement to Acquire Ception Therapeutics
11. Vical Signs Binding Letter of Intent for Sales and Marketing of Allovectin-7(R) in Turkey
Post Your Comments:
(Date:6/26/2016)... June 27, 2016  VMS Rehab Systems, Inc. ( ... take whatever measures required to build a strong and ... is currently listed on the OTC Markets-pink current trading ... and CEO, "We are seeing an anomaly in market ... not only by the Company, but shareholders and market ...
(Date:6/24/2016)... CAMBRIDGE, Mass. , June 24, 2016 /PRNewswire/ ... the Spaulding Rehabilitation Network,s Dean Center for ... of Physical Medicine and Rehabilitation, MIT Hacking Medicine, ... Center for Innovation, today announced the five finalists ... Hackathon for Lyme disease.  More than 100 scientists, ...
(Date:6/24/2016)... and SAN CLEMENTE, Calif. , June ... -based mobile pulmonary function testing company, is now able to ... devices developed by ndd Medical Technologies , Inc. ... done in hospital-based labs.  Thanks to ndd,s EasyOne PRO ® , ... , can get any needed testing done in the comfort of ...
Breaking Medicine Technology:
(Date:6/25/2016)... , ... June 25, 2016 , ... Austin residents seeking ... American College of Mohs Surgery and to Dr. Russell Peckham for medical and surgical ... effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by ...
(Date:6/25/2016)... Oklahoma City, Oklahoma (PRWEB) , ... June 25, ... ... to helping both athletes and non-athletes recover from injury. Recently, he has implemented ... for the Oklahoma City area —Johnson is one of the first doctors to ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is ... associated with chronic pain and the benefits of holistic treatments, Serenity Recovery Center ... suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is a disorder of ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Comfort Keepers® of ... Cancer Society and the Road To Recovery® program to drive cancer patients to and ... other adults to ensure the highest quality of life and ongoing independence. Getting ...
(Date:6/24/2016)... ... June 24, 2016 , ... Puradigm® & Innovative Solutions ... initiated cultivation and processing operations at its production facility, and opened its first ... is the manufacturer of a complete system of proactive air and surface purification ...
Breaking Medicine News(10 mins):