Dear Colleagues,
Please find details below of a free, one hour long educational web tutorial
detailing the practical application of adaptive trials, both multiple stage
designs and response adaptive designs. The target audience is clinical
development teams as a whole and the presentation will not be particularly
statistical. The presentation will be given from a scientific viewpoint
and will not be Company promotional. Practical issues in implementation and
how to address them will be presented.
The presentation will be given by
Dr Paul Sanders
Associate Director, Pfizer Ltd.
&
Graham Nicholls
Product Manager, ClinPhone
Dates and times are as follows:
Mon 11 Dec 2006: 3.00 pm UK Time, 4.00 pm CET, 5.00pm EET, 10.00am US
East Coast Time
Tue 12 Dec 2006: 5.00 pm UK Time, 6.00 pm CET, 7.00pm EET, 12.00pm US
East Coast Time
Visit www.clinphone.com/webinars to review full 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 receive any queries on content
or timing.
Kind Regards,
Malcolm
Malcolm Morrissey
Statistician
ClinPhone Group Ltd
-----------------------------------------------------------------------------------------------------------------------------------------
Re-designing Drug Development: practical application of adaptive trials
Agenda
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 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 we will discuss the current regulatory
thinking and overview the two common types of adaptive trial designs:
multiple stage designs, where planned changes to the study design are made
due to accumulating trial data; and response adaptive designs, where the
treatment assignment of patients is influenced by previous patient responses
or outcomes.
We are pleased to welcome Dr Paul Sanders, Associate Director, Pfizer Ltd.,
as key speaker in this hour-long webinar. Dr Sanders and Graham Nicholls,
Product Manager, ClinPhone, will explore practical considerations important
to clinical development teams in designing and implementing adaptive
studies. Using case studies, the speakers will discuss specific issues such
as maintaining the study blind; practical approaches to keeping design
modifications hidden from Investigators; endpoint development; interactions
with Data Monitoring Committees; and how technologies such as IVR, EDC and
ePRO can be used and configured to facilitate the efficient execution of
adaptive trials.
_________________________________________________________________
The new Windows Live Toolbar helps you guard against viruses
http://toolbar.live.com/?mkt=en-gb
|