Featuring a summary of the updated ICMJE recommendations, an investigation into the enforcement of clinical trial reporting laws, an independent report aiming to improve the transparency of open access services, and the new article format coming to PLOS ONE.
Bringing transparency into focus via The Publication Plan
In December 2019, the International Committee of Medical Journal Editors (ICMJE) released their updated recommendations for the conduct, reporting, editing and publication of medical research. To increase transparency, the recommendations now require authors to disclose both financial and non-financial relationships and activities rather than just conflicts of interest. The recommendations note that the citation of papers published in predatory or pseudo-journals should be avoided, but the suggestion against citing conference abstracts in published work has now been removed. The recommendations also clearly state that study approval by an independent review body does not constitute a ICMJE requirement for clinical trial registration. For more information, please find the full updated recommendations here.
Should the FDA and the NIH do more to enforce clinical trial reporting rules? via Science
After a 2007 US law failed to convince trial sponsors to comply with mandatory posting of clinical trial outcomes to a federal database, the US Food and Drugs Administration (FDA) and the National Institutes of Health (NIH) enacted a ‘final rule’ requiring the results of all trials registered on ClinicalTrials.gov to be posted to the database within one year of study completion. Despite promising the US government aggressive enforcement and penalties for clinical trial sponsors who would not be compliant, the FDA and the NIH have not enforced the aforementioned law. A Science study that examined 4768 clinical trials showed that 31.6% of them had no results reported (as of September 2019). Of the 184 clinical trial sponsor organizations involved in these studies, 30 did not meet a single deadline for clinical trial results reporting and failed to report any results for 67% of their trials. Overall, EU Trials Tracker has estimated that US$6 billion could have been collected in ClinicalTrials.gov penalties, had the law been enforced. In response to these allegations, the FDA has stated that it will not inflict penalties sponsors, who could face up fines of up to US$12 103 a day for failing to report trial results, until the agency has issued further guidance on how it will exercise its power.
The new framework for transparent open access via Information Power
This week, Information Power published an independent report that aims to improve the transparency of open access services and prices; the report is based on a project that was funded by the Wellcome Trust and UK Research and Innovation on behalf of cOAlition S to inform the development of Plan S. With input from funders, libraries, publishers and universities, the report promotes a customer-centric framework that will make the nature and costs of open access publishing more transparent. It also emphasizes that changes to publisher reporting requirements need to be clearly outlined in tried and tested guidelines. With this in mind, cOAlition S has agreed to pilot and refine such a framework during the first quarter of 2020. In a statement given to Information Power, Robert Kiley (Wellcome Trust and cOAlition S) expressed his delight over the engagement of research stakeholders in the development of the framework. However, with half of all medical research funded by pharma, one may wonder why the pharma industry was not consulted.
‘Registered Reports’ – coming soon to PLOS ONE via PLOS Blogs
PLOS ONE has announced that it will soon offer prospective authors the chance to preregister their research. By submitting a Registered Report Protocol (RRP) explaining the study rationale, methods and ethical approvals needed, researchers will be able to receive peer review feedback before study initiation. If the RRP is accepted, authors will then be able to proceed with their investigation in the knowledge that the full study, including their research findings, will be published in PLOS ONE. All reviewers’ comments will be posted alongside the RRP and the research paper to ensure that the review process is transparent and that the appropriate credit is given to peer reviewers. More information on the benefits of Registered Reports is available here.
