What’s Wrong with Phase II Trials? Genetic Engineering News Dr. Miller noted that the use of adaptive designs “should go a long way in increasing the likelihood of a successful early-phase clinical trial. … http://www.genengnews.com/analysis-and-insight/what-s-wrong-with-phase-ii-trials/77899364/

Adaptive designs for clinical trials are being used increasingly in many areas of medical research. An adaptive design differs from a traditional design in … http://jco.ascopubs.org/content/29/6/606.full

Don Berry is a featured presenter in a free webinar on Adaptive Trial Design taking place on Monday January 31st 2011 . Using Bayesian adaptive clinical trial design, the sample size in a clinical trial can be greatly reduced, and multiple treatment options can be evaluated for different patient subgroups. This webinar is for investigators, clinical trialists, [...]

“One of the examples we’ve being using for a while now to demonstrate and teach FACTS is a dose finding trial around an HIV treatment. This has now been worked up into quite a detailed example, examining what benefits accrue in this case from different design features such: as dose response modeling, longitudinal modeling, adaptation [...]

“I attended IQPC’s conference on “Innovation in Clinical Design and Analysis Reporting” in London last week. This was a good conference with a lot of good speakers. As well many interesting case studies, there were two talks, one on reimbursement and the other on analysing and reporting safety data which made me realise that there [...]

“We are excited about a new grant award from NIH and FDA, joint with the University of Michigan, to explore adaptive designs in the NETT trials.  Don Berry and Roger Lewis, representing Berry Consultants, and Bill Barsan from the University of Michigan are PIs on the award.  We will be working closely with the design [...]

It was very heartening to read that Margaret Hamburg, commissioner of the FDA, is actively supportive of the development of new techniques for studying the safety and efficacy of new medicines. In particular to read that approaches such as adaptive clinical trials should be looked at. The FDA clearly recognise the increasing complexity of drug [...]

Along with Bradley Carlin, Don Berry and Jack Lee, I gave the course “Bayesian Adaptive Methods for Clinical Trials” at the August 2010 Joint Statistical Meeting in Vancouver where it was selected for an Excellence in Continuing Education award.  I will be re-running this course in San Francisco on October 10th 2010, www.sfasa.org/bayesOct2010.htm and we have been [...]

A source book for Bayesian adaptive trial design is now available “Bayesian Adaptive Methods for Clinical Trials” (Chapman & Hall/CRC Biostatistics Series) Scott M. Berry (Author), Bradley P. Carlin (Author), J.Jack Lee (Author), Peter Muller (Author), ISBN 978-1439825488.  Available on Amazon or all good book stores.

In Feb 2010 the FDA issued a draft guidance for industry on “Adaptive Design Clinical Trials for Drugs and Biologics” (pdf).  Join me in this on-demand webinar as I quiz adaptive trial gurus Prof Don Berry and Dr Scott Berry on the implications of the FDA Guidance. I will be getting answers to the key [...]