Guide to Plan S compliance in OJS

“For cOAlition S funded research covered by Plan S requirements, all peer-reviewed scholarly articles must be published in venues that fulfil the “Requirements for Publication Venues.” Individual publication venues (such as journals publishing on OJS) are responsible for ensuring that they meet these requirements. Journals that do not meet these requirements will not be suitable for scholarly articles resulting from cOAlition S-funded research.

Many of the Plan S requirements for publication venues represent best practices for quality, discoverability, and interoperability in scholarly publishing. We recommend that journals adopt these practices regardless of whether they intend to publish scholarly articles resulting from Coalition S-funded research….

This guide is intended for journals published on OJS which intend to meet the Requirements for Publication Venues articulated by Plan S under Part III: Technical Guidance and Requirements. This guide is modelled around the Plan S requirements, with sections of this guide mirroring the sections (1.1 and 1.2) of the Plan S requirements. The guide provides specific recommendations for implementing the requirements in OJS. Where suitable we have linked to other PKP documentation and guidance which provides additional details on the implementation of specific features and specifications.

While we will do our best to keep this guide up-to-date, the Plan S documentation should be relied upon for the most current and detailed information….”

Clinical trial results for $3.2 billion Covid drug are missing in action

“The results of most clinical trials of the Covid drug molnupiravir (Lagrevio) have not been made public and remain completely unknown, a new study has found.

 

 

 

The drug is currently being administered to Covid patients in the United States, the UK, and India. The World Health Organisation has issued a “conditional recommendation” for its use in some patient groups. Global sales so far stand at $3.2 billion….”

Evaluation of publication bias for 12 clinical trials of molnupiravir to treat SARS-CoV-2 infection in 13,694 patients | Research Square

Abstract:  Introduction:

During the COVID-19 pandemic, Merck Sharp and Dohme (MSD) acquired the global licensing rights for molnupiravir. MSD allowed Indian manufacturers to produce the drug under voluntary license. Indian companies conducted local clinical trials to evaluate the efficacy and safety of molnupiravir.

Methods

Searches of the Clinical Trials Registry-India (CTRI) were conducted to find registered trials of molnupiravir in India. Subsequent investigations were performed to assess which clinical trials had been presented or published.

Results

According to the CTRI, 12 randomised trials of molnupiravir were conducted in India, in 13,694 patients, starting in late May 2021. By July 2022, none of the 12 trials has been published, one was presented at a medical conference, and two were announced in press releases suggesting failure of treatment. Results from three trials were shared with the World Health Organisation. One of these three trials had many unexplained results, with effects of treatment significantly different from the MSD MOVE-OUT trial in a similar population.

Discussion

The lack of results runs counter to established practices and leaves a situation where approximately 90% of the global data on molnupiravir has not been published in any form. Access to patient-level databases is required to investigate risks of bias or medical fraud.

Ten simple rules for maximizing the recommendations of the NIH data management and sharing plan | PLOS Computational Biology

Abstract:  The National Institutes of Health (NIH) Policy for Data Management and Sharing (DMS Policy) recognizes the NIH’s role as a key steward of United States biomedical research and information and seeks to enhance that stewardship through systematic recommendations for the preservation and sharing of research data generated by funded projects. The policy is effective as of January 2023. The recommendations include a requirement for the submission of a Data Management and Sharing Plan (DMSP) with funding applications, and while no strict template was provided, the NIH has released supplemental draft guidance on elements to consider when developing a plan. This article provides 10 key recommendations for creating a DMSP that is both maximally compliant and effective.

 

EU Clinical Trials Register – Update

“Following the issuing of the Joint Letter by the European Commission, EMA and HMA, National Competent Authorities and European Medicines Agency have sent reminders to sponsors who were not compliant with the European Commission guideline on results posting. Thanks to these reminders, the percentage of posted results substantially increased. However, for some trials the reminders were not successful: detailed lists of these trials can be found here. …”

Clinical Trial Registry Errors Undermine Transparency | The Scientist Magazine®

“Confusion about terminology on the world’s largest clinical trials registry may be delaying the release of drug trial results and undermining rules designed to promote transparency, an investigation by The Scientist has found. 

Key study dates and other information are entered into the ClinicalTrials.gov database by trial researchers or sponsors, and are used by US science and regulatory agencies to determine legal deadlines by which results must be reported. The rules are supposed to ensure timely public access to findings about a potential therapy’s harms and benefits, as well as provide the scientific community with an up-to-date picture of the status of clinical research.

But neither the agencies nor staff overseeing the database routinely monitor individual trial records for veracity, instead relying on the person in charge of a given record to correctly declare information such as when a study ends and how many people were enrolled. …”

Adoption of World Health Organization Best Practices in Clinical Trial Transparency Among European Medical Research Funder Policies | Global Health | JAMA Network Open | JAMA Network

Abstract:  Importance  Research funders can reduce research waste and publication bias by requiring their grantees to register and report clinical trials.

Objective  To determine the extent to which 21 major European research funders’ efforts to reduce research waste and publication bias in clinical trials meet World Health Organization (WHO) best practice benchmarks and to investigate areas for improvement.

Design, Setting, and Participants  This cross-sectional study was based on 2 to 3 independent assessments of each funder’s publicly available documentation and validation of results with funders during 2021. Included funders were the 21 largest nonmultilateral public and philanthropic medical research funders in Europe, with a combined budget of more than US $22 billion.

Exposures  Scoring of funders using an 11-item assessment tool based on WHO best practice benchmarks, grouped into 4 broad categories: trial registries, academic publication, monitoring, and sanctions. Funder references to reporting standards were captured.

Main Outcomes and Measures  The primary outcome was funder adoption or nonadoption of 11 policy and monitoring measures to reduce research waste and publication bias as set out by WHO best practices. The secondary outcomes were whether and how funder policies referred to reporting standards. Outcomes were preregistered after a pilot phase that used the same outcome measures.

Results  Among 21 of the largest nonmultilateral public and philanthropic funders in Europe, some best practices were more widely adopted than others, with 14 funders (66.7%) mandating prospective trial registration and 6 funders (28.6%) requiring that trial results be made public on trial registries within 12 months of trial completion. Less than half of funders actively monitored whether trials were registered (9 funders [42.9%]) or whether results were made public (8 funders [38.1%]). Funders implemented a mean of 4 of 11 best practices in clinical trial transparency (36.4%) set out by WHO. The extent to which funders adopted WHO best practice items varied widely, ranging from 0 practices for the French Centre National de la Recherche Scientifique and the ministries of health of Germany and Italy to 10 practices (90.9%) for the UK National Institute of Health Research. Overall, 9 funders referred to reporting standards in their policies.

Conclusions and Relevance  This study found that many European medical research funder policy and monitoring measures fell short of WHO best practices. These findings suggest that funders worldwide may need to identify and address gaps in policies and processes.

PLOS and OA Switchboard Announce Partnership – The Official PLOS Blog

“The Public Library of Science (PLOS) and the OA Switchboard today announced a partnership that will enable PLOS to better manage its Open Access publishing agreements with institutions, while also providing greater transparency and metadata to our stakeholders, including consortia, libraries and funders.

PLOS was part of the founding working group that sought to tackle the challenge of supporting funder policies, realizing agreements and developing new business models to support a broader move to Open Access (OA) publishing, and the result was the OA Switchboard which was launched in 2020 by the Open Access Scholarly Publishing Association (OASPA) to serve OA publishers, research institutions and funders alike….”

Transformative? | Clarke & Esposito

“cOAlition S has released a report analyzing the first year of the Transformative Journal (TJ) program. As a reminder, TJs (not to be confused with TAs, or Transformative Agreements) are individual hybrid journals that have agreed to (try to) show an “annual increase in the proportion of open access (OA) research content of at least 5% points in absolute terms, and at least 15% in relative terms, year-on-year.” The journal must also publicly agree to flip to OA when 75% of its research content is published OA. These promises allow the hybrid journal to be considered compliant with Plan S and eligible for article processing charge (APC) funds.

 
The report shows that more than half (56%) of the 2,304 journals in the program did not meet their first-year OA targets. The coalition has extended its requirements another year, keeping all TJs in the program (although they must meet year 2 targets calculated as if the journal had met its year 1 numbers). 
 
Removing 56% of the journals would result in 1,290 fewer publication venues for Plan S-funded researchers, which is perhaps part of the reason for the extension. 

Notably, many of the TJs have failed to meet another cOAlition S requirement: a public statement showing how the presence of OA articles has reduced the subscription price of the journal. Elsevier and Springer Nature (182 and 1,714 TJs, respectively) instead have offered “a more generic, anti-double dipping statement,” which apparently has been accepted for 2021, but will not fly for 2022. This raises the question of how a publisher would practically be able to show such a metric. …”

 

A meta-research study of randomized controlled trials found infrequent and delayed availability of protocols – ScienceDirect

Abstract:  Objectives

Availability of randomized controlled trial (RCT) protocols is essential for the interpretation of trial results and research transparency.

Study Design and Setting

In this study, we determined the availability of RCT protocols approved in Switzerland, Canada, Germany, and the United Kingdom in 2012. For these RCTs, we searched PubMed, Google Scholar, Scopus, and trial registries for publicly available protocols and corresponding full-text publications of results. We determined the proportion of RCTs with (1) publicly available protocols, (2) publications citing the protocol, and (3) registries providing a link to the protocol. A multivariable logistic regression model explored factors associated with protocol availability.

Results

Three hundred twenty-six RCTs were included, of which 118 (36.2%) made their protocol publicly available; 56 (47.6% 56 of 118) provided as a peer-reviewed publication and 48 (40.7%, 48 of 118) provided as supplementary material. A total of 90.9% (100 of 110) of the protocols were cited in the main publication, and 55.9% (66 of 118) were linked in the clinical trial registry. Larger sample size (>500; odds ratio [OR] = 5.90, 95% confidence interval [CI], 2.75–13.31) and investigator sponsorship (OR = 1.99, 95% CI, 1.11–3.59) were associated with increased protocol availability. Most protocols were made available shortly before the publication of the main results.

Conclusion

RCT protocols should be made available at an early stage of the trial.

Many researchers say they’ll share data — but don’t

“Most biomedical and health researchers who declare their willingness to share the data behind journal articles do not respond to access requests or hand over the data when asked, a study reports1. …

But of the 1,792 manuscripts for which the authors stated they were willing to share their data, more than 90% of corresponding authors either declined or did not respond to requests for raw data (see ‘Data-sharing behaviour’). Only 14%, or 254, of the contacted authors responded to e-mail requests for data, and a mere 6.7%, or 120 authors, actually handed over the data in a usable format. The study was published in the Journal of Clinical Epidemiology on 29 May….

Puljak’s results square with those of a study that Danchev led, which found low rates of data sharing by authors of papers in leading medical journals that stipulate all clinical trials must share data2. …

Past research suggests that some fields, such as ecology, embrace data sharing more than others. But multiple analyses of COVID-19 clinical trials — including some from Li4,5 and Tan6 — have reported that anywhere from around half to 80% of investigators are unwilling or not planning to share data freely….

To encourage researchers to prepare their data, Li says, journals could make data-sharing statements more prescriptive. They could require authors to detail where they will share raw data, who will be able to access it, when and how.

 

Funders could also raise the bar for data sharing. The US National Institutes of Health, in an effort to curb wasteful, irreproducible research, will soon mandate that grant applicants include a data-management and sharing plan in their applications. Eventually, they will be required to share data publicly….”

Advancing code sharing in the computational biology community | PLOS Computational Biology

“On March 30, 2021, a new code sharing policy was introduced at PLOS Computational Biology [1]. This policy requires any code supporting a publication to be shared unless there are ethical or legal restrictions that prevent sharing. The policy was introduced in response to community desire for a stronger position on code sharing to reflect the fact that the majority of the community already voluntarily share code [2,3]. This community-driven support for open science practices aligns well with the PLOS mission, and, therefore, the implementation of the new policy was a logical progression for the journal. The policy focuses on increasing code sharing as its primary aim, which, in turn, will support reproducibility, and so is not prescriptive to authors about how or where to share their code. The policy (https://journals.plos.org/ploscompbiol/s/code-availability) allows authors to comply in ways which work for them. By the end of the first year of the policy, we expected to see an increase in code sharing rates (the percentage of published research articles that share code) without any negative impact on the publishing demographics or the author, editor, and journal staff experiences. This Editorial reports on the impact of policy over the first 12 months, provides a longitudinal view of code sharing in the journal since 2019, and articulates how this effort can move forward to enhance further sharing, reproducibility, and openness.”