Blinding in pharmaceutical clinical trials: An overview of points to consider

Abstract

Blinding is a corner-stone for the robustness of many clinical trials. Achieving a robust level of trial blinding involves close partnership across a number of trial disciplines, and numerous challenges can arise. This paper provides a wide-ranging overview of issues to consider in managing blinding, including clinical and statistical considerations, supply planning and inventory management strategy, and the management and disclosure of unplanned unblinding events that arise during trial conduct.

Keywords: Bias; Blinding; Double blind; Randomized controlled trial.