Challenges in implementing adaptive designs: comments on the viewpoints expressed by regulatory statisticians.
This is a discussion of the following three papers appearing in this special issue on adaptive designs: 'FDA's critical path initiative: A perspective on contributions of biostatistics' by Robert T. O'Neill; '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.
Gallo
Paul
P
Novartis Pharmaceuticals, East Hanover, NJ, USA.
Maurer
Willi
W
D001699:Biometry; D017326:Clinical Trials, Phase III as Topic / Q000706:statistics & numerical data*; D012107:Research Design / Q000706:statistics & numerical data*; D014481:United States; D014486:United States Food and Drug Administration