Biostatistical and Medical Experts to Interactively Examine Growing Use of New Flexible Trial Designs in Cancer Treatment Clinical Research
CAMBRIDGE, Mass. and PHOENIX, March 24, 2011 /PRNewswire/ -- Cytel, a leading provider of adaptive clinical trial services and software, jointly announced with oncology-focused CRO Medelis, the opening of registration for their April 7 webinar "Transforming Oncology Development With Adaptive Studies".
Over 50% of confirmatory clinical studies today end in failure – a distressing reality, especially for oncologists and developers of cancer treatments. Fortunately, increasing use of validated adaptive designs is helping reverse this discouraging trend.
With their improved probability of successful outcome, adaptive trials are increasingly proposed and accepted by international regulatory agencies. Download the FDA's guidance at: www.fda.gov, search: "download adaptive guidance".
Bridging the gap between statistical innovations and clinical reality, the webinar program will educate all oncology treatment stakeholders: study sponsors, their investors, the medical community, and regulators. The webinar centers on the breakthrough adaptive Promising Zone "de-risking" strategy now accepted for pivotal phase 3 development studies.
The April 7 webinar speakers: noted oncology advisor Dr. John Grous from Medelis and Cytel President and Co-Founder Cyrus Mehta, PhD. Together, they'll examine two actual, adaptive confirmatory studies currently underway.
Download Reference Publications
Recommended webinar references include the U.S. Food and Drug Administration's Adaptive Trials Guidance, providing biopharmaceutical study sponsors the established metrics to confidently utilize adaptive methods. The recent peer-reviewed publication Adaptive Increase in Sample Size when Interim Results are Promising documents the underlying Promising Zone statistical technique, adaptive Sample Size Re-estimation.
About the Session
Thursday, April 7th, 2011
11:00 AM – 12:00 PM EDT
Register free at: http://bit.ly/cytelwebinar
Cytel pioneered the statistical and computational science of adaptive clinical trials and has designed more validated adaptive trials than any other service provider.
Medelis is an oncology focused CRO with the depth of expertise and agility to
deliver accurate results quickly.
From our advisory board to our project managers and CRAs, Medelis offers deep experience in every facet of the oncology drug development process at all levels of our organization.
SOURCE Cytel Inc.