Short abstract

Clinical trial patient level data is rarely made available. Journal policy requiring data access for editors when a paper is accepted has demonstrated high levels of trial data provision, evidence that it prompts some authors re-check their data, and an ability to detect problems pre-publication.

Long abstract

With ongoing concerns about the replicability of published scientific research, there is interest in making study documents available to review - including individual patient data. This is of particular interest in clinical randomised controlled trials, because of their high costs and long duration. However, efforts to make data available post publication have had mixed results, where data statements, even when present, do not guarantee data will be provided.

As a result of ongoing concerns about trial integrity in the anaesthetic literature, the journal ‘Anaesthesia’, from 2019 has had a policy of requesting individual patient data for all trials being accepted for publication. This has allowed an editor to reproduce trial findings, and investigate for signs of failures of research integrity, where both checks are now routine.

Authors have provided anonymised participant data to editors in > 87% of cases, higher than other studies have shown for data requests post publication. Additionally, when asked to provide data, 9% find errors in their own results. We have also discovered that most of the research integrity failures we have found included false data, and many could only be identified with individual data.

Data request at the point of article submission or acceptance may represent a model for how failures of research integrity could be detected and (in some cases) ameliorated, since at this stage incentives appear better aligned: authors would like to be published, and journals would like to avoid retractions. However, limited resources and expertise may prevent this from being widely undertaken.