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Dear colleagues, 

Below please find details of a one hour-long, educational web tutorial relating to response adaptive clinical trials. The talks will be given from a scientific viewpoint – they will not be Company promotional. 
Times are: 
Tuesday, January 18th, 2011 – Europe: 3.00 pm UK; 4.00pm CET; 5.00pm EET; US 10:00 am EST
Thursday, January 20th, 2011 – Europe: 6.00pm UK; 7.00pm CET; 8.00pm EET; US 1:00 pm EST 
http://perceptive.com/news/webinars/2011/implementing-bayesian-response-adaptive-trials/

If you are interested, please register via the link above - there is no need to reply direct to me, although I am happy to answer any queries on content, timing or registration.

Kind regards,

Malcolm
 
Malcolm Morrissey
Perceptive Informatics 


Webinar Topic: Implementing Bayesian Response Adaptive Trials

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 
 
The speakers are :
Damian McEntegart
Senior Director of Statistics and Product Support
Perceptive Informatics
Damian leads the group that provides all specialist support on statistics, medication management and electronic patient-reported outcomes for Perceptive Informatics. Damian has worked as a statistician in the pharmaceutical industry for 25 years. 
 
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. 		 	   		  
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