Anavex Life Sciences Corp (AVXL)

[drv17]

Workshop session at CTAD
Makemdaze - I would like to get your thoughts on this session on Friday.
If I interpret this correctly it looks like Anavex's approach to trials might get discussed by Paul Aisen (member of our SAB).


WORKSHOP
New Trends in Clinical Trial Designs In Search of
Next Generation Treatments
Part I: Assessing a potential disease modifying
effect: Delayed Start Design and Analysis
Paul Aisen, MD
Alzheimer’s Therapeutic Research Institute, University of Southern California, San
Diego, CA, USA
One of the key interests in developing the next generation
AD treatments is demonstrating a potential disease modifying
effect. Delayed start design has been proposed as a viable
clinical trial design to assess whether an observed treatment
effect is due to symptomatic effect or disease modifying
effect. This approach was endorsed in the FDA draft guidance
for clinical development of AD drugs. This short course will
introduce the background of the Delayed Start design, provide
key considerations of design elements, and describe novel
statistical analysis methods and interpretation of results.
Examples from actual clinical trials in AD that have implemented
the design and analysis will be shared. There will be time for
Q&A and interactions with participants