CAMBRIDGE, Mass., Oct. 31 /PRNewswire/ -- Cytel Inc, the leading provider of clinical trial consulting services and software, announced today that Cytel's Dr. Jerald Schindler will present an FDAnews Audioconference "Adaptive Clinical Trial Design: How to Lower Costs and Shorten Product Development Cycles" on Tuesday, October 31, 2006 from 1:30 PM to 3:00 PM EST.
In this instructional conference and Q/A session, Dr. Schindler, president, Cytel Pharmaceutical Research Services, will help attendees decide how to begin implementing new adaptive clinical trial designs. Dr. Schindler will offer strategies to meet FDA guidelines, how adaptive trials can provide more specific information on a drug's efficacy, how a lagging trial may be refined to rescue a drug and how to accomplish these without compromising the integrity of the trial process.
FDA data indicates that traditionally designed clinical trials have not kept pace with today's clinical demands. Government statistics show only 9% of drug compounds that enter the clinical trial system exit as FDA-approved pharmaceuticals. Scott Gottlieb, FDA deputy commissioner for medical and scientific affairs, said the "opportunity couldn't be riper" for the continued development of adaptive trial methods.
"Trial methodology innovations, including use of Bayesian statistics and flexible adaptive trials, are clearly the future of clinical development," said Dr. Schindler. "Cytel has spent the past 20 years developing the supporting statistical methods. Now, our Pharmaceutical Research Services are helping a growing number of sponsors design and launch adaptive clinical trials."
Said Matt Salt, Publisher FDAnews, "We're very excited to have Dr. Schindler, an avowed adaptive clinical trials expert, present during this event."
Topics covered during this 90-minute audio conference include: * Advantages and limitations of adaptive clinical trials * FDA positions on adaptive trial design use across CDER/CDRH divisions * Drug and device companies already using adaptive designs
Event details, including registration information, at: http://www.fdanews.com/wbi/conferences/adaptivectdesign.html
About Instructor Jerald S. Schindler, Dr.P.H.
President of Cytel Pharmaceutical Research Division; previously served as chief biostatistician and global head of Biostatistics and Clinical Technology at Wyeth Research. He has served on the industry advisory board for the Clinical Data Interchange Standards Consortium (CDISC), and has co-led a working group at PhRMA to develop an industry perspective on adaptive clinical trials. He has written and spoken widely on the subject of adaptive clinical trials and their implementation.
About Cytel
Cytel Inc. is the leading provider of clinical trial consulting services and specialized statistical software for the biopharmaceutical, medical device, academic and research institute markets. Cytel's innovative trial designs reduce development costs and facilitate better decisions that increase the probability of clinical trial successes. Entering its 20th year, Cytel Inc. is headquartered in Cambridge MA, with developmental facilities in Pune, India.
Cytel Inc.CONTACT: Michael Weitz of Cytel Inc., +1-617-528-7132, mike@cytel.com
Web site: http://www.cytel.com//
