title: A regulatory view on adaptive/flexible clinical trial design.
abstract: Recently there is growing interest in use of adaptive or flexible designs for development of pharmaceutical products. Statistical methodology has been greatly advanced in the literature. However, there are still some important issues with the methodology and application. In addition, there are many other challenges with these designs, including efficiency of these designs in the entire development program, trial conduct and logistics, the infrastructure of an adaptive trial, the regulatory evaluation of trial results and trial conduct, etc. Up till now, regulatory experience in these designs is very limited. We share some of the challenges.
authors.affiliation: Division of Biometrics I, OB/OTS/CDER/FDA, Rockville, MD, USA. hsienming.hung@fda.hhs.gov
authors.forename: H M James
authors.initials: HM
authors.lastname: Hung
authors.forename: Robert T
authors.initials: RT
authors.lastname: O'Neill
authors.forename: Sue-Jane
authors.initials: SJ
authors.lastname: Wang
authors.forename: John
authors.initials: J
authors.lastname: Lawrence
mesh_terms: D001699:Biometry; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D012107:Research Design; D018401:Sample Size