This page is maintained by the PhRMA
adaptive design working group (
Alex
Dmitrienko).
Training courses presented by members of
the Working Group.
Training course presented at the FDA/Industry
Statistics Workshop (Sep 27, 2006)
General introduction (Mike Krams, Wyeth), terminology and classification
(Vlad Dragalin, Wyeth), adaptive seamless designs (Jeff Maca,
Novartis), sample size reestimation and group sequential designs
(Keaven Anderson, Merck), logistic, operational and regulatory
issues (Paul Gallo, Novartis) [
Download
handouts].
Four-part web-based training series organized
by the Biopharmaceutical Section of the American Statistical Association
(
Alex
Dmitrienko, Chair of Distance Training), PhRMA Adaptive Design
Working Group and PhRMA Adaptive Dose-Ranging Studies Working
Group presented on Oct 10, 2007, Nov 17, 2007, Dec 7, 2007 and
Jan 10, 2008 [
Web-based training program].
