Full registration and reporting of all trials at PLOS Medicine
Last week the All Trials campaign, that PLOS has previously supported, issued a document that sets out in more depth and with greater clarity its specific aims and strategies to ensure that all trials are registered and all results reported. The document itself is short and worth reading in full. Of note, there are two issues that relate very directly to journal policies that have prompted a review at PLOS Medicine and that has led us to revising how we handle some trials – and which we hope will provide a framework for other journals to consider their policies.
First, there needs to be a change in how journals handle unregistered trials. Previously, we were strong supporters of insisting on prospective registration and we, like many other journals, have rejected a number of trials that did not fulfill these criteria. Now, however, while still expecting that prospective registration to be the norm, we will consider retrospectively registered trials for publication provided that:
- The authors register the trial during the review process at the very latest
- They explain the reason for late registration within the methods section
- They submit a statement in which all authors affirm that any trials on the same or a related drug or intervention they’re involved in are registered, and provide (either there or in the supplementary information) links to the published versions of the trials or the registration numbers. This statement will be published in the methods section.We will commit to making it clear on a published paper if previously undisclosed trials come to light after publication.
Second, we will require that an accurate summary of the trial’s results is submitted to the relevant registry (if there is such a mechanism) within a year of study completion or at the time of publication, whichever is the earliest.
We appreciate that these changes, especially the consideration of retrospectively registered trials, represent an evolution in thinking. But times have moved on. The need to uncover all trials and their results is increasingly urgent (as exemplified by thinking behind the RIAT initiative, which PLOS Medicine supports) and journals need to ensure that they are enablers, not blockers, of initiatives to help ensure increased transparency and accountability.
These are highly constructive measures in ensuring maximum disclosure of clinical trial findings. I am glad PLOS is taking these steps to distance itself from study authors who compromise research and medicine by reporting only positive results.