Clinical and regulatory implications of active run‐in phases in long‐term studies for bipolar disorder

ConclusionExtrapolation of results from enrichment studies to the more general population of patients should be carried out cautiously because average treatment benefits are likely to be less in unselected patients. Clear guidance for regulatory submission of RCTs is needed.

Source: Acta Psychiatrica Scandinavica - December 1, 2013 Category: Psychiatry Authors: A. Cipriani, C. Barbui, J. Rendell, J. R. Geddes Tags: Review Source Type: research