Industry, government, and academic panel discussion on multiple comparisons in a "real" phase three clinical trial.
A Food and Drug Administration (FDA)/Industry/Academic Panel Discussion on multiplicity aspects of a real Phase III clinical trial was held at the Third International Conference on Multiple Comparisons, August 6, 2002, in Bethesda, Maryland. The goal was to develop some consensus among industry, government, and academic statisticians concerning requirements and methods for multiplicity management in typical clinical trials. The session was tape-recorded; this article mostly comes from an edited transcript.
University of Vienna, Vienna, Austria. peter.bauer@univie.ac.at
Peter
P
Bauer
George
G
Chi
Nancy
N
Geller
A Lawrence
AL
Gould
David
D
Jordan
Surya
S
Mohanty
Robert
R
O'Neill
Peter H
PH
Westfall
D017326:Clinical Trials, Phase III as Topic / Q000379:methods*; D004345:Drug Industry / Q000379:methods* / Q000592:standards; D006801:Humans; D018579:Patient Selection; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards