This week, we share our recent blog post on open science in the context of rare diseases. We read about trust in real-world evidence, about the EMA’s new rules on clinical trial transparency and about the need for more evidence on the benefits of open peer review. We learn about a new type of citation count manipulation called “sneaked references” and about the role of operations in scholarly publishing. Finally, we highlight an upcoming cOAlition S webinar marking 5 years of the Plan S initiative.
Open science in the context of rare diseases: a patient perspective via Open Pharma | 10-minute read
Open access to research can be particularly important to the rare disease community, with patients and their caregivers and healthcare professionals often eager to access the limited information available about a specific condition. This article draws on interviews with two individuals living with rare diseases, Rhoda Walker (Patient Advocate with hypermobile Ehlers-Danlos syndrome and Volunteer with the Northern Ireland Rare Disease Partnership) and Aisha Seedat (Patient Advocate with Morquio syndrome and Patient Ambassador for Medics 4 Rare Diseases), who helped us explore open science successes and challenges from their perspective.
Trust in real-world evidence via Current Medical Research and Opinion | 12-minute read
Real-world evidence (RWE) is increasingly being used in regulatory and reimbursement decision-making. However, there are substantial concerns over using RWE in the absence of randomized clinical trial data, with a 2017 paper identifying four key barriers that stifle trust in RWE data. These are: (1) the lack of randomization and the risk of bias; (2) the appropriateness of data sources; (3) the multiplicity of studies; and (4) contradictions in the results of studies. This paper by Richard White (Chief Operating Officer at Oxford PharmaGenesis) provides an update on the progress made in overcoming these barriers to trust in RWE data.
EMA mandate for clinical trial transparency via TranspariMED | 3-minute read
On 5 October 2023, the European Medicines Agency (EMA) announced that study protocols for most clinical trials must be made public on the European CTIS trial registry upon EMA regulatory approval. The new rules state that all phase 2 to 4 trials must be made public as soon as the trial is given the regulatory go-ahead by the EMA. The rules differ for phase 1 trials, for which protocols must be made public either at the same time as the results of the trial or within 30 months of the end of the trial, depending on the age of the trial participants. The EMA is aiming to introduce these new rules by the second quarter of 2024.
More evidence is needed to responsibly open up peer review via PLOS Biology | 8-minute read
Open peer review has grown in popularity over recent years, with the benefits purported to include increased transparency, trustworthiness, validity and participation compared with standard peer review. However, this perspective published in PLOS Biology argues that the evidence base for these claimed benefits is currently “very thin” and that open peer review still faces significant limitations. To help address these problems, the authors of the perspective propose a preliminary research agenda and issue a call to action to gather more evidence on the benefits and limitations of open peer review.
Cooking the books: manipulating citation counts via arXiv | 25-minute read
This preprint reports a new method for manipulating citation counts called “sneaked references”. This is when undue references that aren’t actually cited in the manuscript are instead included in the publication metadata. This harms trusted relationships between publishers, Crossref, digital libraries and bibliometric platforms, and also negatively affects metadata research. This preprint looks into sneaked references and other reference discrepancies in publication metadata and discusses what impact this type of citation manipulation may have on the research community.
To listen to:
The role of operations in scholarly publishing via The Scholarly Kitchen | 30-minute listen
What are “scholarly publishing operations”, and why are they important? Find out in this episode of the Early Career Development Podcast from the Society for Scholarly Publishing! Join hosts Meredith Adinolfi (Vice President of Publishing Operations at Cell Press) and Sara Grimme (Senior Director of Operations of Dimensions Corporate at Digital Science) as they discuss the role of operations in scholarly publishing with Anne Flegel (Head of Academic Book Operations at Oxford University Press) and Midori Baer (Senior Director of Publishing Operations at PNAS), including the essential skills required for operations roles and what an entry-level position consists of.
To engage with:
Webinar: 5 years of Plan S via cOAlition S
Plan S is an open access initiative launched in September 2018 with one main goal; that “all scholarly publications on the results from research funded by public or private grants provided by national, regional and international research councils and funding bodies must be published in open access journals, on open access platforms, or made immediately available through open access repositories without embargo”. Now, 5 years into the project, cOAlition S is hosting a webinar on 2 November 2023 to discuss how Plan S has evolved over that period and what the future holds. You can register for the webinar here.