This page is maintained by the PhRMA adaptive
dose-ranging studies 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].
This half-day course was presented by Prof. Christopher
Coffey (University of Alabama at Birmingham), Dr. Brenda Gaydos
(Lilly) and Dr. José Pinheiro (Novartis) at the Joint Statistical
Meetings (JSM) in Salt Lake City on July 29, 2007.
The course included a summary of the simulation study conducted
by the Working Group in 2005-2006 [
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].
