Active control comparisons: the ideal trial design

Brodie, M.J. and Whitehead, J. (2006) Active control comparisons: the ideal trial design. Epilepsy Research, 68 (1). 69-73 . ISSN 0920-1211 doi: 10.1016/j.eplepsyres.2005.09.025

Abstract/Summary

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.