Dear Colleagues,
Please find details below of a free, hour-long, educational web tutorials relating to Applications in Adaptive Trial Designs. It will be presented by Dr Cyrus Mehta from Cytel and Graham Nicholls from ClinPhone. The webinar will be given from a scientific viewpoint, practical solutions will be discussed with case studies and pros and cons will be presented; it will not be Company promotional.
Monday, 29th October2:00 pm UK time - 3.00pm CET- 4.00pm EET- 10:00 am US East Coast time 
Tuesday, 30th October5:00 pm UK time - 6.00pm CET- 7.00pm EET - 1:00 pm US East Coast time 
Visit www.clinphone.com/webinars to review full speaker details and agenda (also reproduced below) and register today!
If you are interested, please register at the link above - there is no need to reply direct to me, although I am happy to answer any queries on content or timing. 
Kind regards
Malcolm Morrissey
Statistician
ClinPhone
 



Dr Cyrus MehtaCo-founder and President,Cytel Inc. 
Graham NichollsProduct Manager 
Agenda: The implementation and regulatory validity of adaptive trial designs has been a topic of much debate and discussion within the industry recently. 
The implementation and regulatory validity of adaptive trial designs has been a topic of much debate and discussion within the industry recently. Recent high profile studies using "seamless phase II into phase III designs", for example, have shown the potential to make considerable time and cost savings in drug development. As a consequence, the EMEA have published an EU regulatory discussion paper on the subject and FDA have announced their plan to release formal guidelines on adaptive trials in the future.
Broadly, adaptive trials are studies that use accumulating data to modify aspects of the trial. In this webinar, Dr Cyrus Mehta, co-founder Cytel Inc., will describe the approaches to adaptive designs from a conceptual viewpoint, providing the non-statistician with an understanding of how such designs requiring interim analysis or Bayesian dose-response modelling techniques operate in practice. Cyrus will also consider the additional activities required of the statistician and study team in pre-study design and mid-study activities including interaction with the data monitoring committee. 
Dr Mehta will be joined by Graham Nicholls, Product Manager, ClinPhone plc, who will further explore practical aspects of implementing an adaptive design, in particular how technology solutions can be used to smoothly implement design adaptations (such as changes to the randomisation scheme). Graham will also discuss the impact of such designs on trial supply requirements and options available for limiting the impact of such designs on medication overage (including solutions for estimating supply requirements). 
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