Active control comparisons: the ideal trial design.
This report describes the concept for a clinical trial that uses carbamazepine as the gold-standard active control for a study of newly diagnosed patients. The authors describe an endpoint including efficacy and tolerability, and a stopping rule that uses a series of interim analyses in order to reach a conclusion as efficiently as possible without sacrificing reliability.
Brodie
Martin J
MJ
Whitehead
John
J
D000927:Anticonvulsants / Q000627:therapeutic use*; D002985:Clinical Protocols; D004827:Epilepsy / Q000188:drug therapy*; D006801:Humans; D017063:Outcome Assessment, Health Care; D016032:Randomized Controlled Trials as Topic / Q000379:methods*
D000927:Anticonvulsants