Clinical Trial Data-sharing Policies Among Journals, Funding Agencies, Foundations, and Other Professional Organizations: A Scoping Review – Journal of Clinical Epidemiology

Abstract:  Objectives

To identify the similarities and differences in data-sharing policies for clinical trial data that are endorsed by biomedical journals, funding agencies, and other professional organizations. Additionally, to determine the beliefs, and opinions regarding data-sharing policies for clinical trials discussed in articles published in biomedical journals.

 

Study Design

Two searches were conducted, a bibliographic search for published articles that present beliefs, opinions, similarities, and differences regarding policies governing the sharing of clinical trial data. The second search analyzed the gray literature (non-peer-reviewed publications) to identify important data-sharing policies in selected biomedical journals, foundations, funding agencies, and other professional organizations.

 

Results

A total of 471 articles were included after database search and screening, with 45 from the bibliographic search and 426 from the gray literature search. A total of 424 data-sharing policies were included. Fourteen of the 45 published articles from the bibliographic search (31.1%) discussed only advantages specific to data-sharing policies, 27 (27/45; 60%) discussed both advantages and disadvantages, and 4 (4/45; 8.9%) discussed only disadvantages specific. A total of 216 journals (of 270; 80%) specified a data-sharing policy provided by the journal itself. One hundred industry data-sharing policies were included, and 32 (32%) referenced a data-sharing policy on their website. One hundred and thirty-six (42%) organizations (of 327) specified a data-sharing policy.

 

Conclusion

We found many similarities listed as advantages to data-sharing and fewer disadvantages were discussed within the literature. Additionally, we found a wide variety of commonalities and differences — such as the lack of standardization between policies, and inadequately addressed details regarding the accessibility of research data — that exist in data-sharing policies endorsed by biomedical journals, funding agencies, and other professional organizations. Our study may not include information on all data sharing policies and our data is limited to the entities’ descriptions of each policy.

How society publishers practice open science beyond open access publishing? | PUBMET

Abstract:  Scholarly publishing has rapidly moved towards open access (OA) over the last few decades. However, OA publishing is only one part of a larger open science movement. The recent UNESCO recommendation for open science (UNESCO, 2021) defines open science broadly to cover the openness of scientific knowledge, science infrastructures, engagement with societal actors, and dialogue with other knowledge systems. In its recommendations, open scientific knowledge includes OA to scientific publications but also open research data, metadata, open educational resources, software, and source code and hardware. Earlier research about open scientific knowledge from the point of view of academic publishers has mainly been focused on one element such as OA publishing and neglected other elements.

This paper aims to fill this gap by surveying how society publishers in Finland adopted other elements of open scientific knowledge. In Finland, learned societies account for 70% of national journal output (Late et al., 2020) and their publishing model is mainly diamond open access, which excludes author processing charges and relies on publishing subsidies (Pölönen et al., 2020). Furthermore, their activities often go beyond scholarly publishing to include education and research activities such as funding research and collecting and storing research data (Korkeamäki et al., 2019).

We conducted an electronic survey addressed to Finnish learned societies in November 2021 to answer the following research questions: “To what degree society publishers take up the elements of open scientific knowledge including open access to publications, open data, and open education?” (RQ1) and “Are elements of open scientific knowledge cumulative?” (RQ2)

In total 97 society publishers responded (40% response rate). We analysed their responses through nine variables measuring how they adopted different elements of open scholarly knowledge (Table 1) in view of the UNESCO recommendations for open science.

The results show elements related to open scholarly publications prevail. Almost 70% of respondents publish either gold, green, or hybrid OA publications. Most society publishers reported to support open data policies only some do collect, store, and provide open access to research datasets. Furthermore, only a few societies offer training for opening research data. Even so, a high share of publishers offers open education, and some share their educational materials openly. Although earlier studies have reported differences in adopting open science between disciplines (Rousi & Laakso, 2020), our analysis does not support these findings.

However, it has confirmed that adopting the elements of open scholarly knowledge is cumulative, as OA publishers are more likely to take up other elements of open scholarly knowledge. However, adopting all elements is not yet common. Since activities (e.g. collecting research data, offering education, etc.) of publishers other than societies seem to influence the take up of these elements, further research of their activities is needed. For example, it will show how often and how openly these other publishers provide research data or education beyond.

C&RL Data Sharing Policy Survey

“College & Research Libraries (C&RL), the official research journal of the Association of College & Research Libraries, is in the process of developing a data sharing policy to encourage authors to share the data and any documentation underlying the results of their research. The C&RL Editorial Board would like to hear from the journal’s authors and others concerning this forthcoming policy.

 

We are hoping you would be willing to answer a few questions to help inform this effort….”

When open data closes the door: A critical examination of the past, present and the potential future for open data guidelines in journals – Prosser – British Journal of Social Psychology – Wiley Online Library

Abstract:  Opening data promises to improve research rigour and democratize knowledge production. But it also presents practical, theoretical, and ethical considerations for qualitative researchers in particular. Discussion about open data in qualitative social psychology predates the replication crisis. However, the nuances of this ongoing discussion have not been translated into current journal guidelines on open data. In this article, we summarize ongoing debates about open data from qualitative perspectives, and through a content analysis of 261 journals we establish the state of current journal policies for open data in the domain of social psychology. We critically discuss how current common expectations for open data may not be adequate for establishing qualitative rigour, can introduce ethical challenges, and may place those who wish to use qualitative approaches at a disadvantage in peer review and publication processes. We advise that future open data guidelines should aim to reflect the nuance of arguments surrounding data sharing in qualitative research, and move away from a universal “one-size-fits-all” approach to data sharing. This article outlines the past, present, and the potential future of open data guidelines in social-psychological journals. We conclude by offering recommendations for how journals might more inclusively consider the use of open data in qualitative methods, whilst recognizing and allowing space for the diverse perspectives, needs, and contexts of all forms of social-psychological research.

 

Long-term availability of data associated with articles in PLOS ONE | PLOS ONE

Abstract:  The adoption of journal policies requiring authors to include a Data Availability Statement has helped to increase the availability of research data associated with research articles. However, having a Data Availability Statement is not a guarantee that readers will be able to locate the data; even if provided with an identifier like a uniform resource locator (URL) or a digital object identifier (DOI), the data may become unavailable due to link rot and content drift. To explore the long-term availability of resources including data, code, and other digital research objects associated with papers, this study extracted 8,503 URLs and DOIs from a corpus of nearly 50,000 Data Availability Statements from papers published in PLOS ONE between 2014 and 2016. These URLs and DOIs were used to attempt to retrieve the data through both automated and manual means. Overall, 80% of the resources could be retrieved automatically, compared to much lower retrieval rates of 10–40% found in previous papers that relied on contacting authors to locate data. Because a URL or DOI might be valid but still not point to the resource, a subset of 350 URLs and 350 DOIs were manually tested, with 78% and 98% of resources, respectively, successfully retrieved. Having a DOI and being shared in a repository were both positively associated with availability. Although resources associated with older papers were slightly less likely to be available, this difference was not statistically significant, suggesting that URLs and DOIs may be an effective means for accessing data over time. These findings point to the value of including URLs and DOIs in Data Availability Statements to ensure access to data on a long-term basis.

 

 

Embracing the value of research data: introducing the JCHLA/JABSC Data Sharing Policy | Journal of the Canadian Health Libraries Association / Journal de l’Association des bibliothèques de la santé du Canada

Abstract:  As health sciences researchers have been asked to share their data more frequently due to funder policies, journal requirements, or interest from their peers, health sciences librarians (HSLs) have simultaneously begun to provide support to researchers in this space through training, participating in RDM efforts on research grants, and developing comprehensive data services programs. If supporting researchers’ data sharing efforts is a worthwhile investment for HSLs, it is crucial that we practice data sharing in our own research endeavours. sharing data is a positive step in the right direction, as it can increase the transparency, reliability, and reusability of HSL-related research outputs. Furthermore, having the ability to identify and connect with researchers in relation to the challenges associated with data sharing can help HSLs empathize with their communities and gain new perspectives on improving support in this area. To that end, the Journal of the Canadian Health Libraries Association / Journal de l’Association des bibliothèques de la santé du Canada (JCHLA / JABSC) has developed a Data Sharing Policy to improve the transparency and reusability of research data underlying the results of its publications. This paper will describe the approach taken to inform and develop this policy. 

 

Facts and Figures for open research data

“Figures and case studies related to accessing and reusing the data produced in the course of scientific production.”

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….”

Data Sharing and Reanalyses Among Randomized Clinical Trials Published in Surgical Journals Before and After Adoption of a Data Availability and Reproducibility Policy | Medical Journals and Publishing | JAMA Network Open | JAMA Network

Abstract:  Importance  Clinical trial data sharing holds promise for maximizing the value of clinical research. The International Committee of Medical Journal Editors (ICMJE) adopted a policy promoting data sharing in July 2018.

Objective  To evaluate the association of the ICMJE data sharing policy with data availability and reproducibility of main conclusions among leading surgical journals.

Design, Setting, and Participants  This cross-sectional study, conducted in October 2021, examined randomized clinical trials (RCTs) in 10 leading surgical journals before and after the implementation of the ICMJE data sharing policy in July 2018.

Exposure  Implementation of the ICMJE data sharing policy.

Main Outcomes and Measures  To demonstrate a pre-post increase in data availability from 5% to 25% (??=?.05; ??=?0.1), 65 RCTs published before and 65 RCTs published after the policy was issued were included, and their data were requested. The primary outcome was data availability (ie, the receipt of sufficient data to enable reanalysis of the primary outcome). When data sharing was available, the primary outcomes reported in the journal articles were reanalyzed to explore reproducibility. The reproducibility features of these studies were detailed.

Results  Data were available for 2 of 65 RCTs (3.1%) published before the ICMJE policy and for 2 of 65 RCTs (3.1%) published after the policy was issued (odds ratio, 1.00; 95% CI, 0.07-14.19; P?>?.99). A data sharing statement was observed in 11 of 65 RCTs (16.9%) published after the policy vs none before the policy (risk ratio, 2.20; 95% CI, 1.81-2.68; P = .001). Data obtained for reanalysis (n?=?4) were not from RCTs published with a data sharing statement. Of the 4 RCTs with available data, all of them had primary outcomes that were fully reproduced. However, discrepancies or inaccuracies that were not associated with study conclusions were identified in 3 RCTs. These concerned the number of patients included in 1 RCT, the management of missing values in another RCT, and discrepant timing for the principal outcome declared in the study registration and reported in the third RCT.

Conclusions and Relevance  This cross-sectional study suggests that data sharing practices are rare in surgical journals despite the ICMJE policy and that most RCTs published in these journals lack transparency. The results of these studies may not be reproducible by external researchers.

Many researchers were not compliant with their published data sharing statement: mixed-methods study – Journal of Clinical Epidemiology

Abstract:  Objectives

To analyse researchers’ compliance with their Data Availability Statement (DAS) from manuscripts published in open access journals with the mandatory DAS.

 

Study Design and Setting

We analyzed all articles from 333 open-access journals published during January 2019 by BioMed Central. We categorized types of DAS. We surveyed corresponding authors who wrote in DAS that they would share the data. A consent to participate in the study was sought for all included manuscripts. After accessing raw data sets, we checked whether data were available in a way that enabled re-analysis.

 

Results

Of 3556 analyzed articles, 3416 contained DAS. The most frequent DAS category (42%) indicated that the datasets are available on reasonable request. Among 1792 manuscripts in which DAS indicated that authors are willing to share their data, 1670 (93%) authors either did not respond or declined to share their data with us. Among 254 (14%) of 1792 authors who responded to our query for data sharing, only 122 (6.8%) provided the requested data.

 

Conclusion

Even when authors indicate in their manuscript that they will share data upon request, the compliance rate is the same as for authors who do not provide DAS, suggesting that DAS may not be sufficient to ensure data sharing.

Open science practices in general and internal medicine journals, an observational study | PLOS ONE

As part of the Open Science movement, this study aims to analyze the current state of open access and open data policies concerning the availability of articles and raw data of the journals belonging to the category “Medicine, General & Internal” of the Science Citation Index Expanded.

Investigating the Effectiveness of the Open Data Badge Policy at Psychological Science Through Computational Reproducibility

Abstract:  In April 2019, Psychological Science published its first issue in which all research articles received the Open Data badge. We used that issue to investigate the effectiveness of this badge, focusing on the adherence to its stated aim at Psychological Science: ensuring reproducibility of results. Twelve researchers of varying experience levels attempted to reproduce the results of the empirical articles in the target issue (at least three researchers per article). We found that all articles provided at least some data, 6/14 articles provided analysis code or scripts, only 1/14 articles was rated to be exactly reproducible, and 3/14 essentially reproducible with minor deviations. We recommend that Psychological Science require a check of reproducibility at the peer review stage before awarding badges, and that the Open Data badge be renamed “Open Data and Code” to avoid confusion and encourage researchers to adhere to this higher standard.

 

Which solutions best support sharing and reuse of code? – The Official PLOS Blog

“PLOS has released a preprint and supporting data on research conducted to understand the needs and habits of researchers in relation to code sharing and reuse as well as to gather feedback on prototype code notebooks and help determine strategies that publishers could use to increase code sharing.

Our previous research led us to implement a mandatory code sharing policy at PLOS Computational Biology in March 2021 to increase the amount of code shared alongside published articles. As well as exploring policy to support code sharing, we have also been collaborating with NeuroLibre, an initiative of the Canadian Open Neuroscience Platform, to learn more about the potential role of technological solutions for enhancing code sharing. Neurolibre is one of a growing number of interactive or executable technologies for sharing and publishing research, some of which have become integrated with publishers’ workflows….”

Open Data – PLOS

“Publishing in a PLOS journal carries with it a commitment to make the data underlying the conclusions in your research article publicly available upon publication.

Our data policy underscores the rigor of the research we publish, and gives readers a fuller understanding of each study….”

A year of open access

“It’s been just over a year since the journals published by the American Society for Biochemistry and Molecular Biology became fully open access. We asked the editors of the ASBMB’s journals how the transition has gone and what they’re planning for the future. Here’s what they told us….

To achieve gold open access, we partnered with commercial publisher Elsevier; however, it is important to recognize that JBC remains, at its core, a journal “for scientists, run by scientists.” Full editorial control of all manuscripts remains with the editors at JBC. In addition, JBC is one of the few journals that performs data-integrity analysis on the papers it publishes.

But what does the future hold? The implementation of open access raises an equally important aspect of science publishing in 2021 and beyond: open science….”