Planning is a fundamental part of the research process. For clinical trials, this takes the form of a detailed study protocol, which provides precise information about the study objectives, design, proposed participants and planned analyses. One might assume that such a document would be essential reading for anyone evaluating the validity of published trial data. However, study protocols are not easily accessible to most readers.
In a positive move towards transparency, the Annals of Internal Medicine has made it a requirement for authors of manuscripts reporting clinical trial data to submit the original study protocol alongside the trial report. As recently described in The Scientist, any amendments to the protocol should be included and dated and the protocol will be published as a supplement alongside accepted articles. It has been suggested that the move is a response to recent allegations from the COMpare trials project, which found multiple incidences of misreported prespecified outcomes in trials published in the journal, as well as an inaccessible study protocol. However, the executive deputy editor has stated that the change was part of a pre-planned update of the journal.
Doug Altman, co-Editor-in-Chief of Trials, discusses the benefit of making study protocols available in a recent blog from BioMed Central. He argues that publication of the protocol allows people to see exactly what was intended for the study and whether any changes were made to the methods or planned analyses after the trial began. While revisions may be necessary, he maintains that transparency is essential. In addition, he highlights that protocols provide greater details of the study methods compared with journal articles and may also help authors to save space when strict journal word limits are in place. Interestingly, full details of planned statistical analyses are not always included in trial protocols and Doug suggests that, in a move towards full transparency, journals should also publish these as standalone documents.