San Francisco Chapter of the American Statistical
Association December Seminar
Speaker: |
Qi Xia, PhD |
Title: |
Use of phase 2 interim
analysis to expedite drug development decisions |
Time: |
December 9, 2015 4:30-6:00pm (4:30-5:00 networking/refreshment; 5:00-6:00 seminar) |
Location: |
Building 362, Lecture Hall, Gilead Sciences
Inc., 362 Lakeside Drive, Foster City, CA 94404 |
Register: |
Pre-registration is required
for this event. Please send an email to sfasaofficers@gmail.com by Dec 7th 12pm PST with the following
information: Name, and current affiliation |
Abstract:
A randomized Ph2 oncology trial with progression free
survival (PFS) as primary endpoint typically takes around 2 years to gather enough
data for a relatively robust Go/No Go decision making to Ph3. In order to
expedite the drug development timeline and reduce the development cost, we
proposed a consistent decision-making strategy to enable earlier development
decisions without complicating the trial design and compromising the sponsorŐs
ability to identify gaps in knowledge and thoughtfully design the phase 3 trial.
We will first examine the theoretical basis and empirical
evidence from Roche/Genentech oncology trials for using the phase 2 interim analysis to facilitate earlier development decisions that is
consistent with the final phase 2 readout. The predictive probability method
will be applied to determine the early decision criteria incorporating
different levels of historical knowledge into the prior distribution. The false
Go/No Go risks associated with the early decision will be characterized. Lastly
we will address issues related to the benefit, cost and implementation details
when the strategy is being applied to trials in real world from Roche/Genentech
experience.
For direction to Gilead Sciences, Inc., please visit the web site:
http://www.gilead.com/map_foster_city