A consultant's perspective on the regulatory hurdles to adaptive trials.
This is a discussion of the following two papers appearing in this special issue on adaptive designs: 'A regulatory view on adaptive/flexible clinical trial design' by H. M. James Hung, Robert T. O'Neill, Sue-Jane Wang and John Lawrence and 'Confirmatory clinical trials with an adaptive design' by Armin Koch.
Mehta
Cyrus R
CR
Cytel Inc., 675 Massachusetts Ave., Cambridge, MA 02139-3309, USA. mehta@cytel.com
Jemiai
Yannis
Y
D001699:Biometry; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D012107:Research Design / Q000706:statistics & numerical data*; D018401:Sample Size; D012984:Software