Concerns that uploading clinical trial results onto registries will prevent subsequent publication in journals are completely unfounded and an “urban legend”, experts say.
Some academic researchers still worry that if they make trial results public on registries like Clinicaltrials.gov or EudraCT before they have published them in academic journals, journal editors might then reject their manuscripts because the information is already publicly available.
Since academic careers hinge on the ability to get published in high-impact journals, this is potentially serious stuff.
TranspariMED has never heard of a case in which a manuscript was rejected by a journal because trial results were already available on a registry, but to be sure, we asked some experts.
Here is what they told us.
“I’d call this an urban legend. To my knowledge, there are no examples of authors failing to publish or having any difficulties publishing as a result of reporting on a register.”
Evan Mayo-Wilson from the Clinical Trials Registration and Reporting Taskforce,
a network of 500 people who regularly upload results onto trial registries
"We hear this too and constantly ask for examples of it happening in the real world but no one has provided one."
Nick DeVito from the EBM Data Lab,
which built the FDAAA and EU Trials Trackers
"I haven’t heard anything about publication issues."
Francine Lane from TrialScope,
a company that manages disclosure for pharmaceutical companies
"The International Committee of Medical Journal Editors [ICMJE] is very clear that the posting of summary results is not considered prior publication, and that is very clearly stated in several parts of the ICMJE guidelines."
Fiona Godlee, editor of the BMJ,
a leading medical journal
The experiences of leading universities worldwide also show that researchers have nothing to fear.
Because U.S. law and EU rules require summary results to be posted onto trial registries within 12 months of trial completion – far faster than typical journal publication timelines – universities that have achieved regulatory compliance routinely post trial outcomes on registries long before they appear in a journal.
This growing group of transparency pioneers includes leading universities such as Duke, Johns Hopkins, Yale and Oxford. Clearly, their medical researchers continue to get their work published in top journals.
Journal editors have clearly and explicitly stated that posting trial results onto registries is no barrier to subsequent publication in a medical journal.
According to the International Committee of Medical Journal Editors (ICMJE):
“[T]he ICMJE will not consider results posted in the same primary clinical trials register in which the initial registration resides as previous publication if the results are presented in the form of a brief, structured (<500 words) abstract or table.”
The ICYMI has further explained that:
“The ICMJE will not consider as prior publication the posting of trial results in any registry that meets the criteria noted in Section III.L. if results are limited to a brief (500 word) structured abstract or tables (to include participants enrolled, key outcomes, and adverse events). The ICMJE encourages authors to include a statement with the registration that indicates that the results have not yet been published in a peer-reviewed journal, and to update the results registry with the full journal citation when the results are published.”
Let’s put this harmful urban legend to rest, once and for all.
Uploading data into trial registries is not just a box-ticking exercise. It really matters to patients:
Posting results onto registries accelerates medical progress because the 12-month timeline permits rapid results sharing.
Posting results onto registries minimises the risk of a trial never reporting its results and becoming research waste, which can happen when a principal investigator dies or leaves their post during the prolonged process of submitting an academic paper to a succession of medical journals.
Research shows that trial results posted on registries typically give a more comprehensive and accurate picture of patient-relevant trial outcomes than corresponding journal articles do.
Universities and hospitals that want to improve their clinical trial reporting can find a collection of transparency tools, tips and tricks on the TranspariMED website.