title: Adaptive designs in clinical drug development: opportunities, challenges, and scope reflections following PhRMA's November 2006 workshop.
abstract: 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.
authors.affiliation: Wyeth Research, Collegeville, Pennsylvania 19426, USA. kramsm@wyeth.com
authors.forename: Michael
authors.initials: M
authors.lastname: Krams
authors.forename: Carl-Fredrik
authors.initials: CF
authors.lastname: Burman
authors.forename: Vladimir
authors.initials: V
authors.lastname: Dragalin
authors.forename: Brenda
authors.initials: B
authors.lastname: Gaydos
authors.forename: Andrew P
authors.initials: AP
authors.lastname: Grieve
authors.forename: Jose
authors.initials: J
authors.lastname: Pinheiro
authors.forename: Willi
authors.initials: W
authors.lastname: Maurer
authors.forename: Paul
authors.initials: P
authors.lastname: Gallo
mesh_terms: 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