Response: Integrity of randomized clinical trials: Performance of integrity tests and checklists requires assessment

Abstract

We thank Alfirevic, 1 Bolland et al., 2 and Thornton 3 for their interest in our review article. 4 Their comments enrich the discussion concerning the integrity of randomized clinical trials (RCTs).Alfirevic 1 hits the RCT integrity testing nail right on the head-"Sweeping this issue under the carpet by hiding behind imperfect tools should no longer be an option"-and this provides further context to the points raised by Thornton. 3 For systematic reviews, a proposal for upgrading methodology to incorporate integrity assessment, and for RCTs, an international consensus statement, have recently been published. 5,6 The responsibility for trustworthiness is shared by all stakeholders involved in the RCT lifecycle from preapproval to post-publication, and transparency is their guiding principle. RCT authors should take note that, according to Alfirevic, 1 trialists shoulder the lion's share of the burden to prove integrity. His comment 1 concerning the bar for trustworthiness requires careful consideration, as both false positives (genuine RCTs that fail on testing) and false negatives (non-genuine RCTs that pass on testing) are relevant for protecting patients. No doubt this will be a key future research topic.