Comments on the draft guidance on "adaptive design clinical trials for drugs and biologics" of the U.S. Food and Drug Administration.
The U.S. FDA has published a draft guidance on "Adaptive Design Clinical Trials for Drugs and Biologics", which gives regulatory guidance on methodological issues in exploratory and confirmatory clinical trials planned with an adaptive design. This comment summarizes the discussion within the joint working group "Adaptive Designs and Multiple Testing Procedures" of the Austro-Swiss and German regions of the International Biometric Society held at the 90-day public comment period in spring 2010.
Medical University of Vienna, Austria.
Werner
W
Brannath
Hans Ulrich
HU
Burger
Ekkehard
E
Glimm
Nigel
N
Stallard
Marc
M
Vandemeulebroecke
Gernot
G
Wassmer
D015982:Bias; D001688:Biological Products / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D003627:Data Interpretation, Statistical; D017277:Drug Approval / Q000379:methods*; D017408:Guidelines as Topic; D006801:Humans; D015233:Models, Statistical; D015203:Reproducibility of Results; D012107:Research Design; D016896:Treatment Outcome; D014481:United States
D001688:Biological Products