Testing strategies in multi-dose experiments including active control.
Inferential test strategies for multi-arm trials are adapted or proposed for the special situation when more than one dose of a test treatment, placebo and active control(s) are compared. This includes between doses, dose-placebo and dose-active-control comparisons. The procedures refer to situations when detailed comparisons make sense only if the sensitivity of the trial has been shown, for example, if a dose-response relationship or a difference between active control and placebo has been established. Split strategies, hierarchical (assuming an order restriction among doses) or linked procedures are introduced. In linked procedures, equivalence to the active control will be established only if the dose is also shown to be effective as compared to placebo. All the inferential procedures control the experimentwise error rate in the strong sense for the respective sets of null hypotheses considered.
Bauer
P
P
Institut für Medizinische Statistik, Universität Wien, Austria. peter.bauer@univie.ac.at
Röhmel
J
J
Maurer
W
W
Hothorn
L
L
D000477:Alkylating Agents / Q000008:administration & dosage; D017311:Amlodipine / Q000008:administration & dosage; D000787:Angina Pectoris / Q000188:drug therapy; D000818:Animals; D002121:Calcium Channel Blockers / Q000008:administration & dosage; D018849:Controlled Clinical Trials as Topic; D003520:Cyclophosphamide / Q000008:administration & dosage; D003627:Data Interpretation, Statistical; D004305:Dose-Response Relationship, Drug; D006801:Humans; D006873:Hydroquinones / Q000008:administration & dosage; D015162:Micronucleus Tests; D015233:Models, Statistical; D009153:Mutagens / Q000008:administration & dosage; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D010919:Placebos; D011837:Radiation-Protective Agents / Q000008:administration & dosage; D018401:Sample Size; D013723:Teratogens
D000477:Alkylating Agents; D002121:Calcium Channel Blockers; D006873:Hydroquinones; D009153:Mutagens; D004364:Pharmaceutical Preparations; D010919:Placebos; D011837:Radiation-Protective Agents; D013723:Teratogens; D017311:Amlodipine; D003520:Cyclophosphamide; C031927:hydroquinone