Implementing Bayesian Response Adaptive Trials

This is an archived webinar.

Since Bayesian adaptive dose allocation trials were reviewed by the PHRMA working group in 2007, there has been increasing interest in response adaptive allocations. These designs utilize a Bayesian algorithm to model dose response and adjust the allocation rates to each treatment on a frequent basis throughout the trial.

In addition to their complex methodology, these designs require continual rapid access to response data, statistical monitoring of the algorithm properties and performance, as well as seamless regular adjustment to the randomization process.

This webinar will review the 2010 draft FDA guidance on adaptive trials and present case studies to examine the effective implementation and operation of these designs.

Topics to be discussed include:

Implementing practical Bayesian adaptive trials
Performing additional pre-study and during-study requirements
Review of the 2010 draft FDA guidance on adaptive trials

Hear from the following experts:

Damian McEntegart
Senior Director of Statistics and Product Support
Perceptive Informatics

Damian leads the group that provides all specialist support on statistics and medication management for Perceptive Informatics. Damian has worked as a statistician in the pharmaceutical industry for 25 years. He has published over 40 articles and letters on issues relating to randomization methodologies, simulation methods for forecasting trial supply needs and validation of patient-reported outcomes data.

Tom Parke
Head of Clinical Trial Solutions
Tessella

For the past 12 years, Tom has worked on software systems to assist in the design and implementation of adaptive clinical trials. He has worked with a number of large pharmaceutical and small biotech companies and collaborated with several CROs to help make many innovative and ground breaking adaptive trial designs a reality. Tom has worked in software development for over 30 years on systems as diverse as operating systems, compilers, controllers for large pieces of medical equipment and air traffic control systems.