Featuring the return of ‘Unreported clinical trial of the week’, exciting opportunities in the age of digital publishing and a new pilot to make comments on preprints publicly available
‘Unreported clinical trial of the week’ is back! via BMJ Opinion
After a leave of absence, ‘Unreported clinical trial of the week’ by BMJ Opinion is back, naming and shaming clinical trials in breach of legal reporting requirements. This week’s unreported trial (NCT02273739) explored the use of enasidenib (AG-221) in the treatment of solid tumours. Although enasidenib was approved for the treatment of relapsed/refractory acute myeloid leukaemia in 2017, NCT02273739 was the first clinical trial to investigate its off-label use in the treatment of solid tumours.
This phase 1/2 trial, which started in October 2014 and was completed in June 2016, involved 21 adult participants with solid tumours and a mutated IDH2 gene. Unlike standard chemotherapies that target all rapidly dividing cells, AG-221 directly targets tumours expressing the mutated IDH2 gene, delivering precision cancer treatment. Primary endpoints of this trial were the safety and maximum tolerable dose of AG-221. However, despite being completed over 3 years ago, results for this clinical trial are not publicly available.
Although NCT02273739 was completed before January 2017 and is therefore not subject to the reporting requirements outlined in the Food and Drug Administration Amendments Act 2007 Final Rule, the authors of this article highlight the ethical and practical implications of not reporting trial results. Because this is the only known trial investigating the off-label use of enasidenib, the lack of reported results creates a knowledge gap for physicians and patients alike.
Expanding the definition of research publications via The Scholarly Kitchen
In the past, the majority of research was communicated in scholarly articles available online in PDF format. Since the launch of Crossref in 1999, online publications and supplementary data files have been assigned unique digital object identifiers (DOIs). Because scholarly communications now include a wide variety of digital content, it is key that all research outputs are assigned a DOI to ensure all research output is discoverable. The need to assign a DOI to any entity is particularly applicable to conference materials. Gone are the days when access to research presented at a conference was limited to attendees. Posters and oral presentations are more frequently being made available for download after a conference as PDFs and recordings, respectively.
Since last year, a working group established by Crossref and DataCite has been exploring the structure of metadata for conference DOI. Those involved in the FREYA project have focused on expanding the current infrastructure for research identifiers. Although the number of formats available presents an exciting opportunity for more varied forms of scholarly communication, the author concludes by raising concerns about the assessment and maintenance of the quality of these materials.
The benefits of community engagement via PLOS Blogs
Preprints provide researchers with the opportunity to gain feedback from the wider scientific community, often enabling them to address emerging issues based on constructive comments before submitting their work to a peer reviewed journal. Although peer reviewer comments are increasingly being made public, comments on preprints are often privately delivered to the authors. Adding to their agreement with Cold Spring Harbour Laboratories, which allows authors to choose whether to have PLOS post a preprint of their submitted manuscript to bioRxiv, PLOS staff will now be alerted to any comments on preprints submitted to PLOS Computational Biology, PLOS Genetics, PLOS Neglected Tropical Diseases and PLOS Pathogens. Some of these comments will then be used to complement the feedback received from commissioned peer reviewers and will eventually become part of the peer review history of the article upon publication, thus making the review process fully transparent.
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