Delays in reporting and publishing trial results during pandemics: cross sectional analysis of 2009 H1N1, 2014 Ebola, and 2016 Zika clinical trials | BMC Medical Research Methodology | Full Text

Abstract:  Background

Pandemic events often trigger a surge of clinical trial activity aimed at rapidly evaluating therapeutic or preventative interventions. Ensuring rapid public access to the complete and unbiased trial record is particularly critical for pandemic research given the urgent associated public health needs. The World Health Organization (WHO) established standards requiring posting of results to a registry within 12 months of trial completion and publication in a peer reviewed journal within 24 months of completion, though compliance with these requirements among pandemic trials is unknown.

Methods

This cross-sectional analysis characterizes availability of results in trial registries and publications among registered trials performed during the 2009 H1N1 influenza, 2014 Ebola, and 2016 Zika pandemics. We searched trial registries to identify clinical trials testing interventions related to these pandemics, and determined the time elapsed between trial completion and availability of results in the registry. We also performed a comprehensive search of MEDLINE via PubMed, Google Scholar, and EMBASE to identify corresponding peer reviewed publications. The primary outcome was the compliance with either of the WHO’s established standards for sharing clinical trial results. Secondary outcomes included compliance with both standards, and assessing the time elapsed between trial completion and public availability of results.

Results

Three hundred thirty-three trials met eligibility criteria, including 261 H1N1 influenza trials, 60 Ebola trials, and 12 Zika trials. Of these, 139 (42%) either had results available in the trial registry within 12 months of study completion or had results available in a peer-reviewed publication within 24 months. Five trials (2%) met both standards. No results were available in either a registry or publication for 59 trials (18%). Among trials with registered results, a median of 42 months (IQR 16–76 months) elapsed between trial completion and results posting. For published trials, the median elapsed time between completion and publication was 21 months (IQR 9–34 months). Results were available within 24 months of study completion in either the trial registry or a peer reviewed publication for 166 trials (50%).

Conclusions

Very few trials performed during prior pandemic events met established standards for the timely public dissemination of trial results.

Exploring Open Access Practices, Attitudes, and Policies in Academic Libraries

Preprint at: https://ir.library.illinoisstate.edu/cgi/viewcontent.cgi?article=1128&context=fpml

Abstract:  This article reports the results of a 2019 survey of academic librarians that investigated their attitudes, practices, and policies regarding open access (OA). This study asks if academic librarians write policies to ensure that they approach OA intentionally and systematically across all library services. The results indicate that, though librarians report favorable beliefs about OA and integrating OA into technical and public services, they seldom create OA policies.

 

Commentary: The publication pandemic

“The rise of OA and the megajournals has turned out to be a lucrative model for publishing houses.1,2 But is it good for the scientific community as a whole? Opinions on this differ from field to field, with the more translational fields, like biology and medicine, taking a more enthusiastic stance and more fundamental fields, like mathematics and physics, a more skeptical one. (See the commentary by Jason Wright in Physics Today, February 2020, page 10, and reference 3.)

There is also a noticeable generational difference of opinion. Some younger scientists view the trend toward OA scientific journals more favorably than their older colleagues do. …”

Update Swiss Elsevier R&P Agreement – June 2021 | Open Access Monitoring

“After a first disillusioning analysis of the Swiss Elsevier Read & Publish Agreement (2020-2023) in August 2020, it is time for another update after 18 months of contract duration….

The low degree of exploitation is not due to the fact that Swiss authors publish less with Elsevier. Rather, many publications that could/should actually be Open Access by agreement remain Closed Access. My monitoring now shows 560 such Swiss Corresponding Author Papers, whose total APC list price amounts to €1.5 million. Publications for which Elsevier does not publish the submission date and therefore the eligibility cannot be determined with certainty are not even included in this number. Example: 10.1016/j.cagd.2021.102003

Why so many papers are closed access seems to have several reasons. I have received feedback from two authors that the option to OA was not displayed in the submission process, leading to suspicion that the affiliation identification at Elsevier is not working reliably.

 

Other authors apparently deliberately chose not to use the OA option because they feared hybrid costs. Since the Swiss OA community (and the SNSF) has been making researchers aware of hybrid and double-dipping for the past 15 years, this is actually good news….

An increase to 61% OA is without doubt a clear improvement over subscription-only. But the cost of this step is extremely high. Currently, the PAR fee for 2020 is over 6000€. If the quota is fully utilised, the PAR fee will come to 4500€ EUR….

Unfortunately, my conclusion from last year does not change much. Those responsible for this deal have quite unnecessarily embarked on something half-baked that no one can really be satisfied with (except Elsevier). It is true that the increase to 61% OA is positive, but only as long as one does not know the price. When I also learn that Swiss OA responsibles now have to chase authors when the submission did not work out with OA, we are actually at the point where we could have reached the 61% via Green Road OA without embargo with the same effort, but much less money. The millions could have been put into more worthwhile alternatives….”

Intellectual Property Rights VS Open Access Initiatives – KS Legal and Associates

“The conflict between open access and traditional IP rights is becoming a significant problem. The essence of IPR and open access is that they are opposed to one another, to the point that approving one is destructive to the other. Let’s break down and find a balance between them….

The basics of open access, as can be shown, contravene one of the most fundamental concepts of intellectual property rights, which is to safeguard intellectual property….”

Intellectual Property Rights VS Open Access Initiatives – KS Legal and Associates

“The conflict between open access and traditional IP rights is becoming a significant problem. The essence of IPR and open access is that they are opposed to one another, to the point that approving one is destructive to the other. Let’s break down and find a balance between them….

The basics of open access, as can be shown, contravene one of the most fundamental concepts of intellectual property rights, which is to safeguard intellectual property….”

Wary EU vows to keep its research open to ‘most’ of the world | Science|Business

“Brussels presented a new global research agenda on Tuesday, committing to a more cautious approach to cooperation with foreign science powers, while at the same time pledging to reinvigorate ties with an EU-friendly US administration.

The blueprint, which has been in the works for months,  sets out “nuanced and modulated” rules of engagement with foreign countries based on “levels of reciprocity, a level playing field, and the respect for fundamental rights and shared values,” while protecting EU-funded research from those seeking to abuse the system.

Among other measures, the blue print promises:

A shift to cooperation around new strategic goals, such as the dual green and digital transition. The EU will adapt cooperation with particular countries and regions in light of this approach, giving priority to cooperation with countries in the wider European neighbourhood, to Africa, and to “like-minded” industrialised and emerging economies.
To weigh openness against the EU’s evolving pursuit of strategic autonomy, which could mean revising and limiting cooperation with certain foreign actors.
To boost the involvement of member states in setting the EU’s global science path…. 

Notably, the old ethos of “open to the world” espoused by former research commissioner Carlos Moedas is gone, to be replaced by “open to most of the world”….

The sharing of research data facing the COVID-19 pandemic | SpringerLink

Abstract:  During the previous Ebola and Zika outbreaks, researchers shared their data, allowing many published epidemiological studies to be produced only from open research data, to speed up investigations and control of these infections. This study aims to evaluate the dissemination of the COVID-19 research data underlying scientific publications. Analysis of COVID-19 publications from December 1, 2019, to April 30, 2020, was conducted through the PubMed Central repository to evaluate the research data available through its publication as supplementary material or deposited in repositories. The PubMed Central search generated 5,905 records, of which 804 papers included complementary research data, especially as supplementary material (77.4%). The most productive journals were The New England Journal of Medicine, The Lancet and The Lancet Infectious Diseases, the most frequent keyword was pneumonia, and the most used repositories were GitHub and GenBank. An expected growth in the number of published articles following the course of the pandemics is confirmed in this work, while the underlying research data are only 13.6%. It can be deduced that data sharing is not a common practice, even in health emergencies, such as the present one. High-impact generalist journals have accounted for a large share of global publishing. The topics most often covered are related to epidemiological and public health concepts, genetics, virology and respiratory diseases, such as pneumonia. However, it is essential to interpret these data with caution following the evolution of publications and their funding in the coming months.

From the body of the paper: “In global public health emergencies, it should be mandatory to disseminate any information that may be of value in fighting the crisis. For this to be done efficiently, there is a need to develop agreed global standards for sharing data and results for scientists, institutions and governments.”

Lost Green OA articles from Semantic Scholar

“Over the last two weeks, one of the largest repositories we index, Semantic Scholar, removed most of the articles it had been hosting. The end result for Unpaywall is that about 1 million formerly Green OA articles are now Closed. This is about 12% of all Green OA. We’re working on finding new locations for as many articles as we can.

The total number of articles removed from Semantic Scholar was about 8 million, but most of them are still OA because we had other locations….”