Research methodology and characteristics of journal articles with original data, preprint articles and registered clinical trial protocols about COVID-19

Authors : Mahir Fidahic, Danijela Nujic, Renata Runjic, Marta Civljak, Zvjezdana Lovric Makaric, Livia Puljak

Background

The research community reacted rapidly to the emergence of COVID-19. We aimed to assess characteristics of journal articles, preprint articles, and registered trial protocols about COVID-19 and its causal agent SARS-CoV-2.

Methods

We analyzed characteristics of journal articles with original data indexed by March 19, 2020, in World Health Organization (WHO) COVID-19 collection, articles published on preprint servers medRxiv and bioRxiv by April 3, 2010.

Additionally, we assessed characteristics of clinical trials indexed in the WHO International Clinical Trials Registry Platform (WHO ICTRP) by April 7, 2020.

Results

Among the first 2118 articles on COVID-19 published in scholarly journals, 533 (25%) contained original data. The majority was published by authors from China (75%) and funded by Chinese sponsors (75%); a quarter was published in the Chinese language.

Among 312 articles that self-reported study design, the most frequent were retrospective studies (N = 88; 28%) and case reports (N = 86; 28%), analyzing patients’ characteristics (38%). Median Journal Impact Factor of journals where articles were published was 5.099.

Among 1088 analyzed preprint articles, the majority came from authors affiliated in China (51%) and were funded by sources in China (46%). Less than half reported study design; the majority were modeling studies (62%), and analyzed transmission/risk/prevalence (43%).

Of the 927 analyzed registered trials, the majority were interventional (58%). Half were already recruiting participants. The location for the conduct of the trial in the majority was China (N = 522; 63%).

The median number of planned participants was 140 (range: 1 to 15,000,000). Registered intervention trials used highly heterogeneous primary outcomes and tested highly heterogeneous interventions; the most frequently studied interventions were hydroxychloroquine (N = 39; 7.2%) and chloroquine (N = 16; 3%).

Conclusions

Early articles on COVID-19 were predominantly retrospective case reports and modeling studies. The diversity of outcomes used in intervention trial protocols indicates the urgent need for defining a core outcome set for COVID-19 research.

Chinese scholars had a head start in reporting about the new disease, but publishing articles in Chinese may limit their global reach. Mapping publications with original data can help finding gaps that will help us respond better to the new public health emergency.

URL : Research methodology and characteristics of journal articles with original data, preprint articles and registered clinical trial protocols about COVID-19

DOI : https://doi.org/10.1186/s12874-020-01047-2

FAIRness Literacy: The Achilles’ Heel of Applying FAIR Principles

Authors : Romain David, Laurence Mabile, Alison Specht, Sarah Stryeck, Mogens Thomsen, Mohamed Yahia, Clement Jonquet, Laurent Dollé, Daniel Jacob, Daniele Bailo, Elena Bravo, Sophie Gachet, Hannah Gunderman, Jean-Eudes Hollebecq, Vassilios Ioannidis, Yvan Le Bras, Emilie Lerigoleur, Anne Cambon-Thomsen, The Research Data Alliance – SHAring Reward and Credit (SHARC) Interest Group

The SHARC Interest Group of the Research Data Alliance was established to improve research crediting and rewarding mechanisms for scientists who wish to organise their data (and material resources) for community sharing.

This requires that data are findable and accessible on the Web, and comply with shared standards making them interoperable and reusable in alignment with the FAIR principles. It takes considerable time, energy, expertise and motivation.

It is imperative to facilitate the processes to encourage scientists to share their data. To that aim, supporting FAIR principles compliance processes and increasing the human understanding of FAIRness criteria – i.e., promoting FAIRness literacy – and not only the machine-readability of the criteria, are critical steps in the data sharing process.

Appropriate human-understandable criteria must be the first identified in the FAIRness assessment processes and roadmap. This paper reports on the lessons learned from the RDA SHARC Interest Group on identifying the processes required to prepare FAIR implementation in various communities not specifically data skilled, and on the procedures and training that must be deployed and adapted to each practice and level of understanding.

These are essential milestones in developing adapted support and credit back mechanisms not yet in place.

URL : FAIRness Literacy: The Achilles’ Heel of Applying FAIR Principles

DOI : http://doi.org/10.5334/dsj-2020-032

Research Data Management Status of Science and Technology Research Institutes in Korea

Authors : Myung-seok Choi, Sanghwan Lee

Recent advances in digital technology and the data-driven science paradigm has led to a proliferation of research data, which are becoming more important in scholarly communications.

The sharing and reuse of research data can play a key role in enhancing the reusability and reproducibility of research, and data from publicly funded projects are assumed to be public goods. This is seen as a movement of open science and, more specifically, open research data.

Many countries, such as the USA, UK, and Australia, are pushing ahead with implementing policies and infrastructure for open research data. In this paper, we present survey results pertaining to the creation, management, and utilization of data for researchers from government-funded research institutes of science and technology in Korea.

We then introduce recent regulations stipulating a mandated data management plan for national R&D projects and on-going efforts to realize open research data in Korea.

URL : Research Data Management Status of Science and Technology Research Institutes in Korea

DOI : http://doi.org/10.5334/dsj-2020-029

Responsible, practical genomic data sharing that accelerates research

Authors : James Brian Byrd, Anna C. Greene, Deepashree Venkatesh Prasad, Xiaoqian Jiang, Casey S. Greene

Data sharing anchors reproducible science, but expectations and best practices are often nebulous. Communities of funders, researchers and publishers continue to grapple with what should be required or encouraged.

To illuminate the rationales for sharing data, the technical challenges and the social and cultural challenges, we consider the stakeholders in the scientific enterprise. In biomedical research, participants are key among those stakeholders.

Ethical sharing requires considering both the value of research efforts and the privacy costs for participants. We discuss current best practices for various types of genomic data, as well as opportunities to promote ethical data sharing that accelerates science by aligning incentives.

URL : Responsible, practical genomic data sharing that accelerates research

DOI : https://doi.org/10.1038/s41576-020-0257-5

Research Data Management as an Integral Part of the Research Process of Empirical Disciplines Using Landscape Ecology as an Example

Authors : Winfried Schröder, Stefan Nickel

Research Data Management (RDM) is regarded as an elementary component of empirical disciplines. Taking Landscape Ecology in Germany as an example the article demonstrates how to integrate RDM into the research design as a complement of the classic quality control and assurance in empirical research that has, so far, generally been limited to data production.

Sharing and reuse of empirical data by scientists as well as thorough peer reviews of knowledge produced by empirical research requires that the problem of the research in question, the operationalized definitions of the objects of investigation and their representative selection are documented and archived as well as the methods of data production including indicators for data quality and all data collected and produced.

On this basis, the extent to which this complemented design of research processes has already been realized is demonstrated by research projects of the Chair of Landscape Ecology at the University of Vechta, Germany.

This study is part of a joined research project on Research Data Management funded by the German Federal Ministry of Education and Research.

URL : Research Data Management as an Integral Part of the Research Process of Empirical Disciplines Using Landscape Ecology as an Example

DOI : http://doi.org/10.5334/dsj-2020-026

Data Communities: Empowering Researcher-Driven Data Sharing in the Sciences

Authors : Rebecca Springer, Danielle Cooper

There is a growing perception that science can progress more quickly, more innovatively, and more rigorously when researchers share data with each other. However many scientists are not engaging in data sharing and remain skeptical of its relevance to their work.

As organizations and initiatives designed to promote STEM data sharing multiply – within, across, and outside academic institutions – there is a pressing need to decide strategically on the best ways to move forward. In this paper, we propose a new mechanism for conceptualizing and supporting STEM research data sharing.

Successful data sharing happens within data communities, formal or informal groups of scholars who share a certain type of data with each other, regardless of disciplinary boundaries. Drawing on the findings of four large-scale qualitative studies of research practices conducted by Ithaka S+R, as well as the scholarly literature, we identify what constitutes a data community and outline its most important features by studying three success stories, investigating the circumstances under which intensive data sharing is already happening.

We contend that stakeholders who wish to promote data sharing – librarians, information technologists, scholarly communications professionals, and research funders, to name a few – should work to identify and empower emergent data communities.

These are groups of scholars for whom a relatively straightforward technological intervention, usually the establishment of a data repository, could kickstart the growth of a more active data sharing culture. We conclude by offering recommendations for ways forward.

URL : Data Communities: Empowering Researcher-Driven Data Sharing in the Sciences

DOI : https://doi.org/10.2218/ijdc.v15i1.695

Data-sharing recommendations in biomedical journals and randomised controlled trials: an audit of journals following the ICMJE recommendations

Authors : Maximilian Siebert, Jeanne Fabiola Gaba, Laura Caquelin, Henri Gouraud, Alain Dupuy, David Moher, Florian Naudet

Objective

To explore the implementation of the International Committee of Medical Journal Editors (ICMJE) data-sharing policy which came into force on 1 July 2018 by ICMJE-member journals and by ICMJE-affiliated journals declaring they follow the ICMJE recommendations.

Design

A cross-sectional survey of data-sharing policies in 2018 on journal websites and in data-sharing statements in randomised controlled trials (RCTs).

Setting

ICMJE website; PubMed/Medline.

Eligibility criteria

ICMJE-member journals and 489 ICMJE-affiliated journals that published an RCT in 2018, had an accessible online website and were not considered as predatory journals according to Beall’s list. One hundred RCTs for member journals and 100 RCTs for affiliated journals with a data-sharing policy, submitted after 1 July 2018.

Main outcome measures

The primary outcome for the policies was the existence of a data-sharing policy (explicit data-sharing policy, no data-sharing policy, policy merely referring to ICMJE recommendations) as reported on the journal website, especially in the instructions for authors.

For RCTs, our primary outcome was the intention to share individual participant data set out in the data-sharing statement.

Results

Eight (out of 14; 57%) member journals had an explicit data-sharing policy on their website (three were more stringent than the ICMJE requirements, one was less demanding and four were compliant), five (35%) additional journals stated that they followed the ICMJE requirements, and one (8%) had no policy online. In RCTs published in these journals, there were data-sharing statements in 98 out of 100, with expressed intention to share individual patient data reaching 77 out of 100 (77%; 95% CI 67% to 85%).

One hundred and forty-five (out of 489) ICMJE-affiliated journals (30%; 26% to 34%) had an explicit data-sharing policy on their website (11 were more stringent than the ICMJE requirements, 85 were less demanding and 49 were compliant) and 276 (56%; 52% to 61%) merely referred to the ICMJE requirements.

In RCTs published in affiliated journals with an explicit data-sharing policy, data-sharing statements were rare (25%), and expressed intentions to share data were found in 22% (15% to 32%).

Conclusion

The implementation of ICMJE data-sharing requirements in online journal policies was suboptimal for ICMJE-member journals and poor for ICMJE-affiliated journals.

The implementation of the policy was good in member journals and of concern for affiliated journals. We suggest the conduct of continuous audits of medical journal data-sharing policies in the future.

URL : Data-sharing recommendations in biomedical journals and randomised controlled trials: an audit of journals following the ICMJE recommendations

DOI : http://dx.doi.org/10.1136/bmjopen-2020-038887