Trials that turn from retrospectively registered to prospectively registered: a cohort study of “retroactively prospective” clinical trial registration using history data

ConclusionsRetroactively prospective trial registration happens in one in 50 trials. While these changes to the start date could be mistakes or legitimate edits based on the most up-to-date information, they could also indicate a retrospectively registered trial that has been made to appear as a prospectively registered trial, which would lead to biases unapparent to reviewers. Our results point to the need for more transparent reporting of changes to a trial ’s details and have implications for the review and conduct of clinical trials, with our fully automated and freely available tools allowing reviewers or editors to detect these changes.Trial registrationThe preregistered protocol of our study is available viahttps://osf.io/rvq53. The most recent version of the protocol lists all deviations from the original study plan, including the rationale behind the changes, and additional analyses that were conducted.
Source: Trials - Category: Research Source Type: clinical trials