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. …”

 

 

Archiving the COVID Tracking Project – Bay Area Open Science Group – LibCal – UC Berkeley Library

“Are you interested in making your research more openly available? Want to learn about open science tools and platforms that can make your research more effective and reproducible? The Bay Area Open Science Group is intended to bring together students, faculty, and staff from the Stanford, Berkeley, and UCSF communities to learn about open science, discuss the application of open science practices in a research context, and meet other members of the community who are interested in (or already are) incorporating open science practices into their work….

Gather around virtually with colleagues at Stanford and Berkeley for a presentation on The COVID Tracking Project by Kevin Miller, a former team lead with the project who is archiving the project’s data and collections for the UCSF Archives & Special Collections. The project was a volunteer-run, community-science program that became a critical source of national pandemic data accidentally and overnight. He will discuss how it was built, and the challenges of archiving such a massive, born-digital collection….”

Why preprints are good for patients | Nature Medicine

“Rapid communication of clinical trial results has likely saved lives during the COVID-19 pandemic and should become the new norm….

But during health emergencies, there are many tensions, one of which is the mismatch between the urgent need for information and evidence and the much longer time frames of scientific peer review and publication. The COVID-19 pandemic is the first global health emergency of the new information age, with data and results widely shared via social media. This has resulted in very real difficulties in distinguishing important information from noise, and real news from fake news. How should the research and medical community best manage this new reality?…

Some may argue that the speed advantage of preprints does not outweigh the risks of poor-quality, misleading or even fraudulent research being published and acted upon. I would counter that clinicians should not rely solely on peer review to assess the validity and meaningfulness of research findings. This is because dubious, perhaps fraudulent data can still get through peer review, as was seen with early COVID papers published and then retracted from two of the most prestigious medical journals. In addition, even valid data can be misleading. There has been an avalanche of observational data that passed peer review and was then used to justify treatments, most notably with hydroxychloroquine, but the susceptibility of observational methodology to moderate biases means that such data should not be the basis of patient care.

I take two lessons from our experience running the largest COVID-19 clinical trial over the last two years. The first is that that the preprint system has come of age, demonstrating huge value in rapidly communicating important research findings. Almost daily I am alerted through social media alerts from trusted sources and colleagues of important new findings published as preprints. A degree of immediate peer review is also available by means of the preprint comments section and from colleagues via social media. The full peer-reviewed manuscripts usually appear many weeks or even months later. I cannot envisage a future without such rapid dissemination of new evidence.

 

Given this new reality, the second lesson is that we must ensure that the medical community and policy makers are sufficiently skilled in critical thinking and scientific methods that they can make sensible decisions, regardless of whether an article is peer reviewed or not.”

Saving Ukrainian Cultural Heritage Online | webinar | May 13, 2022 | San José State University, US

“We invite you to join the SJSU King Library and special guest speakers Anna E. Kijas from Tufts University and Quinn Dombrowski from Stanford University to learn the story behind the grassroots organization Saving Ukrainian Cultural Heritage Online (SUCHO). Time May 13, 2022 12:00 PM in Pacific Time (US and Canada)”

Supporting Ukrainian Editorial Staff: Crowdfunding Campaign

The invasion of Ukraine on 24 February 2022 and the expansion of the war zone across the country have had a significant impact on the country’s scientific activity. Much civilian infrastructure has been destroyed, including higher education and research institutions.

Through a number of programmes, such as Science for Ukraine, support is being provided to Ukrainian researchers, but this support has not been extended to staff working alongside researchers in knowledge generation: the librarians, editors, technicians, and administrative staff at universities, research institutes, and other infrastructures.

Yet preserving the knowledge, expertise, and knowledge-sharing capabilities of these scientific communities is of vital importance.

What can we do to help?

Supporting Ukrainian Editorial Staff (SUES) is an initiative by various European institutions, infrastructures, and organizations (Institute of Literary Research of the Polish Academy of Sciences [IBL-PAN], OPERAS, Directory of Open Access Journals [DOAJ], Directory of Open Access Books [DOAB], Electronic Information for Libraries [EIFL], Association of European University Presses [AEUP]), as well as a number of French scientific publishers, aimed at supporting scientific communication in Ukraine and helping scholarly journals and academic publishers to continue their publishing activities.

Did you know that there are more than 1,000 academic journals in Ukraine? Over 700 of these are open access journals published via the URAN platform. The publication of academic books is also extensive, with more than 20 Ukrainian university presses currently distributed via the CEEOL portal. These publications, in fields ranging from physics to literature via history, sociology, and biology, are key vehicles for the communication of knowledge generated by Ukrainian researchers. The editors, reviewers, typesetters, proofreaders, translators, and technical and administrative staff working in the various publishing centres need your support to continue their mission: to share and disseminate knowledge.

A questionnaire is being circulated around Ukrainian journals and publishers to help accurately identify their needs in terms of financial and technical support. The requests received so far relate primarily to remuneration for editorial work, to enable them to continue their work and to publish the next issue of their journal or their next book. The purpose of this campaign is to help 10 journals or publishers to keep publishing. In the long term, the project is also aimed at strengthening relationships and exchanging knowledge to ensure the international presence and visibility of Ukrainian academic publishers. Thanks to your contribution, Ukrainian scholarly journals and scientific publishers will be able to continue sharing knowledge.

A crowdfunding campaign is being run from Wednesday, 4 May to Monday, 6 June 2022, to raise money to help Ukrainian journals who have requested assistance from the coalition. Unique compensation will be offered in return for any financial support offered.

Link to the crowdfunding webpage: https://wemakeit.com/projects/support-to-ukrainian-editors

Contacts

Research Report: How well did copyright laws serve libraries during COVID-19? – IFLA

“83% of responding library professionals said they had copyright-related challenges providing materials during pandemic-related facility closures. These intersected with ongoing challenges predating the pandemic, including budget pressures, external financial crises, difficult negotiations with publishers, and demand for eBooks that outpaces publisher offerings.

While many publishers offered expanded access to services and content during the early months of the pandemic, these offers usually did not last for sufficient time for libraries to meaningfully integrate them into teaching and research activities. 69% of respondents who had challenges said they included issues providing access to textbooks, and 52% of libraries that had copyright challenges indicated challenges with providing access internationally, as students and faculty returned to their home countries. To access content digitally, some libraries made use of programs such as the HathiTrust’s Emergency Temporary Access project and ‘Resource-Sharing during COVID’ (RSCVD)….”

Helping Ukrainian Scholars, One Book at a Time – Internet Archive Blogs

“The Internet Archive is proud to partner with Better World Books to support Ukrainian students and scholars. With a $1 donation at checkout during your purchase at betterworldbooks.com, you will help provide verifiable information to Ukrainian scholars all over the world through Wikipedia.

Since 2019, the Internet Archive has worked with the Wikipedia community to strengthen citations to published literature. Working in collaboration with Wikipedians and data scientists, Internet Archive has linked hundreds of thousands of citations in Wikipedia to books in our collection, offering Wikipedia editors and readers single-click access to the verifiable facts contained within libraries. 

Recently, our engineers analyzed the citations in the Ukrainian-language Wikipedia, and were able to connect citations to more than 17,000 books that have already been digitized by the Internet Archive, such as the page for ???????? (English translation: Genomics), which links to a science textbook published in 2002. Through this work, we discovered that there are more than 25,000 additional books that we don’t have in our collection—and that’s where you can help! …”

Dismantling the ivory tower’s knowledge boundaries

“The major shift to open access during the pandemic began with the Free Read initiative, which launched the petition “

Unlock Coronavirus Research” for scientists in early February of 2020 and to which highly reputable medical publishers quickly responded. Before the pandemic, up to 75 percent of scholarly publications were behind a paywall. By comparison, a preliminary study of over 5,600 articles on PubMed suggests that more than 95 percent of scholarly articles related to COVID-19 are now freely available. This increase in accessibility resulted from the rapid adaptation by biomedical journals and publishers, including Elsevier, Springer Nature, Cell Press, New England Journal of Medicine, and The Lancet. These journals and publishers granted open access to research on COVID-19 research, often making it 

immediately accessible on the platform PubMed Central and similar public repositories. Free and open access to COVID-19 research quickly became the new normal for biomedicine, with available findings directly impacting the development of treatment protocols and vaccines. Yet the pandemic became more than a health crisis. Understanding the social, psychological, and economic implications of the pandemic were imperative to its continued management.

Social science research, which delivers insights into human behaviors, relationships, and institutions, was instrumental to policymaking and healthcare solution development during the COVID-19 pandemic. The importance of social science research to pandemic management was demonstrated by the 

shift in the topic of COVID-19 papers, from the initial focus on disease modeling, hospital mortality, diagnostics, and testing to an increasing focus on topics such as business closure, remote work, geographic mobility and migration, inequality, managerial decision-making, as well as accelerating innovation. Once the basic science on the virus were established, research on creating societal and economic resilience played an even larger role for beating the COVID-19 pandemic. One clear area that demonstrated the importance of social science research in informing COVID-19 management was the rollout of vaccines. Psychological, marketing, and information systems research played a central role in vaccine uptake across communities. A recent report by the National Institutes of Health called for the use of evidence-based strategies, such as 

behavioral nudges and strategic social norms, to increase vaccine uptake….”

 

 

Watkinson | What has the COVID-19 pandemic taught us about humanities book publishing so far? A view from North America | The Journal of Electronic Publishing

“Ground down for years by the conflation of lack of physical circulation with a lack of interest, humanities publishers saw the passion unleashed when access to monographs became ubiquitous and easy. Publishers who were long-term skeptics of open access have become proponents, although still worried about how to sustain it financially….

How do we help these readers discover books and journals they can access? As the exponential growth of humanities titles in the Directory of Open Access Books (DOAB) and Directory of Open Access Journals (DOAJ) shows, a lot of literature is becoming permanently open access. However, good luck in doing a subject search for just open access content! Because US libraries have outsourced cataloging to companies such as EBSCO and ProQuest that rely on sales revenue to fund human-powered metadata enrichment, there is little incentive to surface open access books or even identify them as such. Small humanities journals are sometimes less visible because their publishers can’t create and distribute metadata (something DOAJ exists to help with). Academic books are also often invisible to the computers that mine full-text and metadata because the standards used in book publishing cater to print rather than electronic discovery. That’s because the trade giants dominate US book publishing and focus on selling bestsellers through Amazon.com rather than serving the needs of academic libraries. The consequence is that humanities book publishers spend all their efforts on BISAC codes (designed to help booksellers in arranging shelves), ONIX feeds (heavy on availability statuses), and ISBNs (using the same 13-digit UPC format as cereal boxes). Their focus on the print supply chain leaves little time for allocating digital object identifiers (DOIs), Open Researcher and Contributor IDs (ORCIDs), or Research Organization Registry (ROR) identifiers, the building blocks of the digital ecosystem. The challenge of managing temporarily free-to-read materials during the pandemic and the switch to open has catalyzed some libraries to rediscover the importance of “technical services” that were in danger of being consigned to the building’s basement. The combination of untapped demand for poorly tamed information has also opened the doors to increasingly sophisticated informal organizations. The pirate site Z-Library, for example, offers millions of books and journal articles for free with a robust search mechanism and clean user interface. Based probably in Russia, outside the boundaries of copyright policing, Z-Library is both a symptom of unmet global demand and an existential threat to many academic publishers’ current sustainability models.

 

How can librarians and publishers sustain an ecosystem of humanities publishing in which access to the digital version of each title is free? Who pays the cost of publishing in fields that lack the grant funding of science, technical, and medical fields (STM)? The recognition that open access models that require authors to pay article processing charges (APCs) or book publishing charges (BPCs) are fundamentally inequitable to the many who cannot pay has led to new “hybrid” funding models. Several North American university presses have combined parent institutional support, payments from individual libraries and consortia, and grant funding where available to support OA book publishing. These include the Direct to Open program from the MIT Press, Fund to Mission from the University of Michigan Press, and the multi-institutional membership model that powers Lever Press. Beyond the university presses, “scholar-led” publishers such as Punctum Books and many library publishers provide options that rely on substantial volunteer labor and support in kind. All of these models rely on library support to a greater or lesser extent. Already under pressure from the inflationary costs of STM periodicals, this funding may not be able to scale. The Toward an Open Monograph Ecosystem (TOME) initiative is jointly led by the Association of American Universities, Association of Research Libraries, and Association of University Presses. This program aims to bring provosts to the table, providing funding for their faculty members to publish books as open access that is separate from the library’s allotment. An open question that the University of North Carolina Press is exploring is whether individual scholars will be willing to spend money on print copies of books that are available open access. Their Sustainable History Monograph Pilot already suggests that this may vary by field….”

Copyright and emergencies: tips for librarians | EIFL

“During the COVID-19 pandemic, librarians in EIFL partner countries began to alert EIFL about problems providing access to educational resources during lockdowns, in particular much needed textbooks. For printed materials in the library’s collection, there are often no licensed electronic versions available, especially for textbooks and other materials in local languages. In this situation, copyright law determines what librarians can and cannot do to alleviate the situation.

EIFL has put together a tip sheet on the steps to take, from a copyright perspective, to guide librarians in emergency situations when institutions are forced to close, for example, due to extreme weather, conflict, or pandemics. There are also links to resources and further information.

If the copyright law does not allow the library to supply a digital copy, unfortunately there often isn’t a quick fix. However, forewarned is forearmed and we hope that the tip sheet will encourage librarians to check their copyright law, and to initiate any national copyright law reforms that are needed to support access to resources for online education now and in any future emergency situations….”

How the Wayback Machine Is Saving Digital Ukraine – IEEE Spectrum

“When the Ukrainian invasion began, the Internet Archive launched several efforts to capture the Ukrainian Internet. Its archivists launched a high-volume crawl through hundreds of thousands of websites ending in “.ua.” They selected specific sites to archive as completely as possible, including government, education, and library sites. And they targeted journalism, particularly Ukrainian news sites and aggregators. The organization has also been supporting others working to save Ukraine’s digital resources, including SUCHO (Saving Ukrainian Cultural Heritage Online) and the Archive Team.

Mark Graham, director of the Internet Archive’s Wayback Machine, explained this dive into Ukraine’s Internet and how it differs from the Wayback Machine’s usual approach to preserving digital history. …”

Serving our community in difficult times: a letter from Kevin Guthrie – ITHAKA

“At the onset of the pandemic in 2020, we promised that fees would not increase for JSTOR participants through 2023. We also introduced a year-long program that provided participating academic institutions with access to all Archive Collections at no additional cost. Since then, we extended that program for another year, and to date nearly 5,000 institutions have taken advantage of it….

Consistent with our mission-driven aspirations, and considering the current public health, economic, and political environment, we have decided to extend the expanded access program to participating higher education institutions for a third year, through June 2023….”

 

Unlocking linked real-world data presents opportunities to improve public health | Impact of Social Sciences

“The COVID-19 pandemic has surfaced the potential and risks of linked real word datasets to accelerate and produce new improvements in public health. In this post, Matthew Franklin, Dan Howdon, Suzanne Mason, Tony Stone, Monica Jones, outline the opportunities and challenges of using real world data as part of the ‘Unlocking data to inform public health policy and practice’ project. Highlighting the ethical and practical challenges of accessing this data, they argue investing in and developing trust across those involved in the formation of real world data is critical to its effective use….”

Open data and data sharing in articles about COVID-19 published in preprint servers medRxiv and bioRxiv

This study aimed to analyze the content of data availability statements (DAS) and the actual sharing of raw data in preprint articles about COVID-19. The study combined a bibliometric analysis and a cross-sectional survey. We analyzed preprint articles on COVID-19 published on medRxiv and bioRxiv from January 1, 2020 to March 30, 2020. We extracted data sharing statements, tried to locate raw data when authors indicated they were available, and surveyed authors. The authors were surveyed in 2020–2021. We surveyed authors whose articles did not include DAS, who indicated that data are available on request, or their manuscript reported that raw data are available in the manuscript, but raw data were not found. Raw data collected in this study are published on Open Science Framework (https://osf.io/6ztec/). We analyzed 897 preprint articles. There were 699 (78%) articles with Data/Code field present on the website of a preprint server. In 234 (26%) preprints, data/code sharing statement was reported within the manuscript. For 283 preprints that reported that data were accessible, we found raw data/code for 133 (47%) of those 283 preprints (15% of all analyzed preprint articles). Most commonly, authors indicated that data were available on GitHub or another clearly specified web location, on (reasonable) request, in the manuscript or its supplementary files. In conclusion, preprint servers should require authors to provide data sharing statements that will be included both on the website and in the manuscript. Education of researchers about the meaning of data sharing is needed.

Associated institutions in Mexico and the US launch the Repository of Documentation on Disappearances in Mexico | CRL

“On March 23-24 the “Truth, Justice, Memory: Documentary Evidence in the Digital Age” conference will take place at El Colegio de México, where the digital platform Repository of Documentation on Disappearances in Mexico (RDDM)

(link is external) will launch.

RDDM is a collaborative initiative between four partner institutions – the Center for Research Libraries (CRL), the Colegio de México (El COLMEX), the Instituto de Investigaciones Jurídicas (IIJ-UNAM) and the Universidad Iberoamericana Ciudad de México (UIA-CDMX). RDDM seeks to gather and safeguard human rights documentation on disappearances in Mexico since the beginning of the War on Drugs in 2006. …”