Adaptive designs in clinical drug development: opportunities, challenges, and scope reflections following PhRMA's November 2006 workshop.
This paper provides reflections on the opportunities, scope and challenges of adaptive design as discussed at PhRMA's workshop held in November 2006. We also provide a status report of workstreams within PhRMA's working group on adaptive designs, which were triggered by the November workshop. Rather than providing a comprehensive review of the presentations given, we limit ourselves to a selection of key statements. The authors reflect the position of PhRMA's working group on adaptive designs.
Krams
Michael
M
Wyeth Research, Collegeville, Pennsylvania 19426, USA. kramsm@wyeth.com
Burman
Carl-Fredrik
CF
Dragalin
Vladimir
V
Gaydos
Brenda
B
Grieve
Andrew P
AP
Pinheiro
Jose
J
Maurer
Willi
W
Gallo
Paul
P
D026661:Clinical Trials Data Monitoring Committees; D002986:Clinical Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D003627:Data Interpretation, Statistical; D004345:Drug Industry; D006801:Humans; D012107:Research Design; D014481:United States; D014486:United States Food and Drug Administration