Ignorance is not bliss: Statistical power is not probability of trial success.
The purpose of this commentary is to place probability of trial success, or assurance, in the context of decision making in drug development, and to illustrate its properties in an intuitive manner for the readers of Clinical Pharmacology and Therapeutics. The hope is that this will stimulate a dialog on how assurance should be incorporated into a quantitative decision approach for clinical development and trial design that uses all available information.
Pfizer Inc, San Diego, California, USA.
M L
ML
Zierhut
Pfizer Inc, San Diego, California, USA.
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P
Bycott
Amgen, Thousand Oaks, California, USA.
M A
MA
Gibbs
Novartis, Cambridge, Massachusetts, USA.
B P
BP
Smith
Pfizer Inc, San Diego, California, USA.
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P
Vicini
D000818:Animals; D001499:Bayes Theorem; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003627:Data Interpretation, Statistical; D055808:Drug Discovery / Q000706:statistics & numerical data*; D006801:Humans; D015233:Models, Statistical; D011336:Probability