Subverting Randomization in Controlled Trials

TLDR

Recent empirical evidence underscores the importance of adequate randomization in controlled trials, yet investigators rarely document the sensitive details of subverting randomization, highlighting bias concerns. The article compiles anonymous accounts of randomization subversion, from envelope transillumination to code searching, and proposes methodological recommendations to prevent deciphering. The study documents a range of subversion tactics, from envelope transillumination to searching principal investigator office files for code. Trials with inadequate allocation concealment show larger treatment effects, and deciphering is more frequent than a mere rate occurrence, underscoring that properly conducted RCTs are essential to avoid bias.

Abstract

Recent empirical evidence supports the importance of adequate randomization in controlled trials. Trials with inadequate allocation concealment have been associated with larger treatment effects compared with trials in which authors reported adequate allocation concealment. While that provides empirical evidence of bias being interjected into trials, trial investigators rarely document the sensitive details of subverting the intended purpose of randomization. This article relates anonymous accounts run the gamut from simple to intricate operations, from transillumination of envelopes to searching for code in the office files of the principal investigator. They indicate that deciphering is something more frequent than a rate occurrence. These accounts prompt some methodological recommendations to help prevent deciphering. Randomized controlled trials appear to annoy human nature--if properly conducted, indeed they should.