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Systematic reviews of health interventions synthesise evidence from all RCTs addressing a particular research question, and are considered very high-quality evidence. Unfortunately, it has become clear that some RCTs included in systematic reviews are not authentic and may have been entirely fabricated. We call trials subject to data falsification, fabrication, or other serious research integrity issues “problematic studies”, and recent examples can be found amongst studies included in systematic reviews of ivermectin for the treatment of COVID-19. However, there is no consensus around how to identify these problematic studies when undertaking a systematic review, and often no checks are performed at all.

In the first half of this MSU web clinic, Jack presented the NIHR-funded INSPECT-SR project, which aims to develop a tool for identifying and excluding problematic RCTs from systematic reviews. The project will combine empirical evidence and consensus science approaches to develop a tool, which will then be refined through testing. He outlined the project, delivered interim results, and provided information about how to participate in the development of the tool.

In the second half, Jack described some of the analytic methods which are employed to assess the authenticity of RCT datasets.

Posted by Rachel Richardson