Why did clinical trial registries fail to prevent Covid research chaos?

“There is a long-standing global ethical obligation to register all trials before they start, shored up by regulatory requirements in some jurisdictions. Data from 18 registries worldwide feed into the WHO-managed International Clinical Trials Registry Platform (ICTRP), providing a continuously updated overview of who is researching what, when, where and how – at least in theory.

 

 

If the registry infrastructure had worked and been used as intended, much of the COVID-19 research chaos would have been avoided.

 

 

For example, researchers considering launching a hydroxychloroquine trial could have searched ICTRP and discovered that the drug was already being investigated by numerous other trials. Those researchers could accordingly have focused on investigating other treatment options instead, or aligned their outcome measures with existing trials. …

The global registry infrastructure has long been inadequately supported by legislators and regulators, and is woefully underfunded.

 

 

 

This persistent neglect of the world’s only comprehensive directory of medical research led to costly research waste on an incredible scale during the pandemic.

 

 

The WHO recommends that member states should by law require every interventional trial to be registered and reported. In addition, WHO recommends that all trial results should be made public specifically on a registry within 12 months, and that registry data should be kept up to date.

 

 

 

By enforcing these three simple rules, regulators would ensure that there is a comprehensive, up-to-date global database of all trials and their results.

 

In reality, existing laws in the EU and the US only cover a small minority of trials and are not being effectively enforced, while many other jurisdictions have no relevant laws at all. …”

 

 

Public access policy in the United States: Impact of the Scholarly Publishing Roundtable – Plutchak – – Learned Publishing – Wiley Online Library

“Key points

 

The Scholarly Publishing Roundtable was formed in 2009 at the request of a US Congressional Committee to develop recommendations for public access policy.
Published in January 2010, the Roundtable’s recommendations had a significant impact on the guidelines for federal funding agencies issued in 2013.
The Roundtable was unique in bringing together individuals holding divergent views about open access policy.
The success of the Roundtable may provide important lessons for policymakers in addressing open access issues….”

Evaluating research assessment | Jisc

“A large-scale review, commissioned by Research England on behalf of the four higher education funding bodies and published by RAND Europe, collected attitudes to the REF in real time as UK institutions prepared their submissions. It gathered views via a survey (with 3,000+ researcher responses), as well as focus groups and one-to-one interviews with researchers, research managers, and institutional leads.

The review also considered the impact of changes made to the REF since the previous exercise in 2014….”

It’s Time to Terminate Social Work’s Relationship with the Impact Factor | Social Work | Oxford Academic

“As a journal-level metric, the IF is unable to assess the value of any given article or author. To make this inference, one would need to read the article and assess its claims, scientific rigor, methodological soundness, and broader implications. What’s more, the IF (which represents the average number of citations across a finite set of eligible articles) is vulnerable to the skewness in citation rates among articles (Nature, 2005) and to the manipulation, negotiation, and gaming of its calculation among stakeholders (Ioannidis & Thombs, 2019). At a more fundamental level the IF does not capture journal functioning such as improvements to (or worsening of) internal evaluative processes (e.g., effectiveness of peer review, changes to submission instructions and policies, use and adherence to reporting guidelines, etc.; Dunleavy, 2022). These and other issues are explored in more depth by Seglen (1997)….

In light of these limitations, social work should de-emphasize the IF and instead embrace a new set of evaluative tools. The San Francisco Declaration on Research Assessment (American Society for Cell Biology, 2013)—and more recently the Leiden Manifesto (Hicks et al., 2015)—typify such efforts. They encourage stakeholders (i.e., academic institutions, journals, funders, researchers) to consider using a multitude of qualitative and quantitative alternative metrics (i.e., “altmetrics”; Priem et al., 2012; see also https://metrics-toolkit.org/metrics/) when judging scholarly output—whether it be a journal article, a grant proposal, or even a hiring or tenure packet. …”

 

Arcadia Fund supports Plazi in its endeavor to rediscover known biodiversity | 16/05/2022

“The Swiss-based Plazi NGO has received a grant of EUR 1.5 million from Arcadia Fund– a charitable fund of Lisbet Rausing and Peter Baldwin – to further develop its Biodiversity Literature Repository(BLR) established in collaboration with Zenodo, the open science repository hosted and managed by the European Organization for Nuclear Research (CERN), and the open-access scholarly publisher and technology provider Pensoft. The Arcadia-supported project helps rediscover known biodiversity by liberating taxonomic treatments, material citations and images trapped in scholarly biodiversity publications, and making them FAIR and open. The project engages the community in the huge and decisive challenge to understand and preserve the biodiversity of our planet. Our knowledge about biodiversity is largely imprisoned in a corpus of more than 500 million pages of scientific research publications that is growing daily. Many of these publications are only available in print, and others are PDFs behind a paywall. These data are not FAIR; they are not findable, accessible, interoperable, or reusable. They cannot be linked to new digital resources such as gene sequences, citizen science observations, taxonomic names, or specimens of digitized natural history collections. Extracting and using text and data from such PDFs comes at very high cost, if possible at all. Through itsTreatmentBank production service, Plazi is a leader in providing access to biodiversity data liberated from publications. Thanks to the Arcadia Fund support and in collaboration with Pensoft, Zenodo and the Swiss Institute for Bioinformatics Literature Services (SIBiLS), Plazi provides access to over 750,000 taxonomic treatments, 450,000 figures and over 1.1 million material citations from over 53,000 publications in the BLR….”

How the Open Book Collective works | Community-led Open Publication Infrastructures for Monographs (COPIM)

by Livy Onalee Snyder and Joe Deville

The Open Book Collective (OBC) is a non-profit membership organization that brings together Open Access (OA) publishers, service providers, librarians, and other supporters to collectively bring about a fairer, more sustainable model of open book publishing. 

Through the OBC’s online platform, publishers and service providers offer individual and collective membership packages which libraries and other potential supporters can pay to join.

[…]

 

How does the growth of a particular publisher’s open access content factor into the relative value of a Big Deal? Part 2: The Findings – Delta Think

“Some final thoughts: (1) Overall usage was a stronger influence on the change in value than the small changes in the proportion of hybrid OA article usage. (2) Despite the range of research activity levels across our institutions, there wasn’t much difference in the proportion of the open versus controlled usage across the site-licensed institutions for either publisher. (3) COVID likely affected these trends, but precisely how was unclear. Did lockdown increase the usage or limit it? Did it affect our two publishers differently? We have no ‘non-COVID’ control unfortunately. (4) If the impact of transformative agreements on the rate of hybrid OA article output influenced these trends, the impact was quite small. Still, with more libraries negotiating transformative agreements, growth in the proportion of OA articles should accelerate. As long as usage in publisher packages continues to grow, cost per controlled use will increase more quickly than cost per use. This new cost per controlled use metric should help libraries track the return on investment from their journal package subscription payments as a growing proportion of underlying articles are free to read.”

The Bookseller – News – Emerald Publishing partners with Knowledge Unlatched for e-book collection

“Emerald Publishing has partnered with Knowledge Unlatched (KU) to create and promote an Open Access e-book collection in business management and economics. 

The exclusive deal starts from 2023 and is the first Open Access partnership of its kind for the publisher within its e-books portfolio.  

All book titles in the “Emerald Publishing – Responsible Management and the SDGs” package will also focus on responding to and achieving the United Nations’ Sustainable Development Goals (SDGs), with a particular focus on SDGs on decent work and economic growth; industry, innovation and infrastructure; and responsible consumption and production. 

Titles will cover themes such as diversity, inclusion and gender and racial equity in the workplace, sustainable tourism and ending forced labour, and how businesses of all sizes are working towards SDGs. …”

Recommendations for repositories and scientific gateways from a neuroscience perspective | Scientific Data

“Digital services such as repositories and science gateways have become key resources for the neuroscience community, but users often have a hard time orienting themselves in the service landscape to find the best fit for their particular needs. INCF has developed a set of recommendations and associated criteria for choosing or setting up and running a repository or scientific gateway, intended for the neuroscience community, with a FAIR neuroscience perspective….”

Diversity, sustainability and quality must be the hallmarks of academic publishing in Europe – The Guild

“Ahead of the June Competitiveness Council, where the ministers will be invited to adopt conclusions on research assessment and implementation of Open Science policies, The Guild urges the member states to ensure that Open Access serves science, not publishers.

While research excellence requires free flow of knowledge, some Open Access strategies and models increase the financial burden on research institutions. Article Processing Charges (APCs), used by some of the Open Access journals, exacerbate the unsustainable situation of journal spending in university libraries and create unequal access to knowledge. Greater transparency on the publication costs for Open Access journals, and fair and transparent contractual arrangements with publishers are crucial for monitoring the proper use of public research funding.

It is important to develop alternative and sustainable non-APC Open Access models. The Guild calls for the member states to support the development and uptake of Diamond Open Access journals and platforms which consist often of community-driven, and academic-led and owned publishing initiatives. Unlike other Open Access models, Diamond Open Access journals and platforms do not charge any fees from the authors or readers. Thus, they can further empower researchers to disseminate their research results, ensuring bibliodiversity and vital academic publishing….”

Diversity, sustainability and quality must be the hallmarks of academic publishing in Europe – The Guild

“Ahead of the June Competitiveness Council, where the ministers will be invited to adopt conclusions on research assessment and implementation of Open Science policies, The Guild urges the member states to ensure that Open Access serves science, not publishers.

While research excellence requires free flow of knowledge, some Open Access strategies and models increase the financial burden on research institutions. Article Processing Charges (APCs), used by some of the Open Access journals, exacerbate the unsustainable situation of journal spending in university libraries and create unequal access to knowledge. Greater transparency on the publication costs for Open Access journals, and fair and transparent contractual arrangements with publishers are crucial for monitoring the proper use of public research funding.

It is important to develop alternative and sustainable non-APC Open Access models. The Guild calls for the member states to support the development and uptake of Diamond Open Access journals and platforms which consist often of community-driven, and academic-led and owned publishing initiatives. Unlike other Open Access models, Diamond Open Access journals and platforms do not charge any fees from the authors or readers. Thus, they can further empower researchers to disseminate their research results, ensuring bibliodiversity and vital academic publishing….”