Archives des mots-clés : research data

Status, use and impact of sharing individual participant data from clinical trials: a scoping review

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Authors : Christian Ohmann, David Moher, Maximilian Siebert, Edith Motschall, Florian Naudet

Objectives

To explore the impact of data-sharing initiatives on the intent to share data, on actual data sharing, on the use of shared data and on research output and impact of shared data.

Eligibility criteria

All studies investigating data-sharing practices for individual participant data (IPD) from clinical trials.

Sources of evidence

We searched the Medline database, the Cochrane Library, the Science Citation Index Expanded and the Social Sciences Citation Index via Web of Science, and preprints and proceedings of the International Congress on Peer Review and Scientific Publication.

In addition, we inspected major clinical trial data-sharing platforms, contacted major journals/publishers, editorial groups and some funders.

Charting methods

Two reviewers independently extracted information on methods and results from resources identified using a standardised questionnaire. A map of the extracted data was constructed and accompanied by a narrative summary for each outcome domain.

Results

93 studies identified in the literature search (published between 2001 and 2020, median: 2018) and 5 from additional information sources were included in the scoping review. Most studies were descriptive and focused on early phases of the data-sharing process. While the willingness to share IPD from clinical trials is extremely high, actual data-sharing rates are suboptimal.

A survey of journal data suggests poor to moderate enforcement of the policies by publishers. Metrics provided by platforms suggest that a large majority of data remains unrequested. When requested, the purpose of the reuse is more often secondary analyses and meta-analyses, rarely re-analyses. Finally, studies focused on the real impact of data-sharing were rare and used surrogates such as citation metrics.

Conclusions

There is currently a gap in the evidence base for the impact of IPD sharing, which entails uncertainties in the implementation of current data-sharing policies. High level evidence is needed to assess whether the value of medical research increases with data-sharing practices.

URL : Status, use and impact of sharing individual participant data from clinical trials: a scoping review

Original location : https://bmjopen.bmj.com/content/11/8/e049228

Open research data repositories: Practices, norms, and metadata for sharing images

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Authors : Karin Hansson, Anna Dahlgren

Open research data repositories are promoted as one of the cornerstones in the open research paradigm, promoting collaboration, interoperability, and large-scale sharing and reuse. There is, however, a lack of research investigating what these sharing platforms actually share and a more critical interface analysis of the norms and practices embedded in this datafication of academic practice is needed.

This article takes image data sharing in the humanities as a case study for investigating the possibilities and constraints in 5 open research data repositories. By analyzing the visual and textual content of the interface along with the technical means for metadata, the study shows how the platforms are differentiated in terms of signifiers of research paradigms, but that beneath the rhetoric of the interface, they are designed in a similar way, which does not correspond well with the image researchers’ need for detailed metadata.

Combined with the problem of copyright limitations, these data-sharing tools are simply not sophisticated enough when it comes to sharing and reusing images. The result also corresponds with previous research showing that these tools are used not so much for sharing research data, but more for promoting researcher personas.

URL : Open research data repositories: Practices, norms, and metadata for sharing images

DOI : https://doi.org/10.1002/asi.24571

Introducing a data availability policy for journals at IOP Publishing: Measuring the impact on authors and editorial teams

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Authors : Jade Holt, Andrew Walker, Phill Jones

As the open research movement continues to gather pace, a number of publishers, funders, and institutions are mandating the sharing of underlying research data. At the same time, concerns about introducing extra quality control steps around data availability statements (DAS) are driving a discussion about the best way to make data more open without slowing down publication.

This article describes a pilot project to introduce a new Open Data policy to three IOP Publishing (IOPP) journals as part of IOPP’s commitment to increasing transparency and support for open science.

An investigation was undertaken using an automated workflow monitoring tool to understand the impact of this change on authors and the editorial staff. Changes in revised submission processing times and how often manuscripts were returned to the author were measured.

An overall increase in the time editorial staff spent processing manuscripts was found as well as an increase in the number of times manuscripts were returned to authors. Detailed analysis shows that manuscripts in which authors claim in the DAS to have included data within the manuscript were the most strongly affected. Steps to mitigate the effects through improved author communication were found to be effective.

URL : Introducing a data availability policy for journals at IOP Publishing: Measuring the impact on authors and editorial teams

DOI : https://doi.org/10.1002/leap.1386

Between administration and research: Understanding data management practices in an institutional context

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Authors : Stefan Reichmann, Thomas Klebel, Ilire Hasani-Mavriqi, Tony Ross-Hellauer

Research Data Management (RDM) promises to make research outputs more transparent, findable, and reproducible. Strategies to streamline data management across disciplines are of key importance.

This paper presents results of an institutional survey (N = 258) at a medium-sized Austrian university with a STEM focus, supplemented with interviews (N = 18), to give an overview of the state-of-play of RDM practices across faculties and disciplinary contexts.

RDM services are on the rise but remain somewhat behind leading countries like the Netherlands and UK, showing only the beginnings of a culture attuned to RDM. There is considerable variation between faculties and institutes with respect to data amounts, complexity of data sets, data collection and analysis, and data archiving.

Data sharing practices within fields tend to be inconsistent. RDM is predominantly regarded as an administrative task, to the detriment of considerations of good research practice. Problems with RDM fall in two categories: Generic problems transcend specific research interests, infrastructures, and departments while discipline-specific problems need a more targeted approach.

The paper extends the state-of-the-art on RDM practices by combining in-depth qualitative material with quantified, detailed data about RDM practices and needs. The findings should be of interest to any comparable research institution with a similar agenda.

URL : Between administration and research: Understanding data management practices in an institutional context

DOI : https://doi.org/10.1002/asi.24492

Research Data Management Challenges in Citizen Science Projects and Recommendations for Library Support Services. A Scoping Review and Case Study

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Authors: Jitka Stilund Hansen, Signe Gadegaard, Karsten Kryger Hansen, Asger Væring Larsen, Søren Møller, Gertrud Stougård Thomsen, Katrine Flindt Holmstrand

Citizen science (CS) projects are part of a new era of data aggregation and harmonisation that facilitates interconnections between different datasets. Increasing the value and reuse of CS data has received growing attention with the appearance of the FAIR principles and systematic research data management (RDM) practises, which are often promoted by university libraries.

However, RDM initiatives in CS appear diversified and if CS have special needs in terms of RDM is unclear. Therefore, the aim of this article is firstly to identify RDM challenges for CS projects and secondly, to discuss how university libraries may support any such challenges.

A scoping review and a case study of Danish CS projects were performed to identify RDM challenges. 48 articles were selected for data extraction. Four academic project leaders were interviewed about RDM practices in their CS projects.

Challenges and recommendations identified in the review and case study are often not specific for CS. However, finding CS data, engaging specific populations, attributing volunteers and handling sensitive data including health data are some of the challenges requiring special attention by CS project managers. Scientific requirements or national practices do not always encompass the nature of CS projects.

Based on the identified challenges, it is recommended that university libraries focus their services on 1) identifying legal and ethical issues that the project managers should be aware of in their projects, 2) elaborating these issues in a Terms of Participation that also specifies data handling and sharing to the citizen scientist, and 3) motivating the project manager to good data handling practises.

Adhering to the FAIR principles and good RDM practices in CS projects will continuously secure contextualisation and data quality. High data quality increases the value and reuse of the data and, therefore, the empowerment of the citizen scientists.

URL : Research Data Management Challenges in Citizen Science Projects and Recommendations for Library Support Services. A Scoping Review and Case Study

DOI : http://doi.org/10.5334/dsj-2021-025

Clinical trial transparency and data sharing among biopharmaceutical companies and the role of company size, location and product type: a cross-sectional descriptive analysis

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Authors : Sydney A Axson, Michelle M Mello, Deborah Lincow, Catherine Yang, Cary P Gross, Joseph S Ross, Jennifer Miller

Objectives

To examine company characteristics associated with better transparency and to apply a tool used to measure and improve clinical trial transparency among large companies and drugs, to smaller companies and biologics.

Design

Cross-sectional descriptive analysis.

Setting and participants

Novel drugs and biologics Food and Drug Administration (FDA) approved in 2016 and 2017 and their company sponsors.

Main outcome measures

Using established Good Pharma Scorecard (GPS) measures, companies and products were evaluated on their clinical trial registration, results dissemination and FDA Amendments Act (FDAAA) implementation; companies were ranked using these measures and a multicomponent data sharing measure.

Associations between company transparency scores with company size (large vs non-large), location (US vs non-US) and sponsored product type (drug vs biologic) were also examined.

Results

26% of products (16/62) had publicly available results for all clinical trials supporting their FDA approval and 67% (39/58) had public results for trials in patients by 6 months after their FDA approval; 58% (32/55) were FDAAA compliant.

Large companies were significantly more transparent than non-large companies (overall median transparency score of 95% (IQR 91–100) vs 59% (IQR 41–70), p<0.001), attributable to higher FDAAA compliance (median of 100% (IQR 88–100) vs 57% (0–100), p=0.01) and better data sharing (median of 100% (IQR 80–100) vs 20% (IQR 20–40), p<0.01). No significant differences were observed by company location or product type.

Conclusions

It was feasible to apply the GPS transparency measures and ranking tool to non-large companies and biologics. Large companies are significantly more transparent than non-large companies, driven by better data sharing procedures and implementation of FDAAA trial reporting requirements.

Greater research transparency is needed, particularly among non-large companies, to maximise the benefits of research for patient care and scientific innovation.

URL : Clinical trial transparency and data sharing among biopharmaceutical companies and the role of company size, location and product type: a cross-sectional descriptive analysis

DOI : http://dx.doi.org/10.1136/bmjopen-2021-053248

Doctoral Students’ Educational Needs in Research Data Management: Perceived Importance and Current Competencies

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Author : Jukka Rantasaari

Sound research data management (RDM) competencies are elementary tools used by researchers to ensure integrated, reliable, and re-usable data, and to produce high quality research results.

In this study, 35 doctoral students and faculty members were asked to self-rate or rate doctoral students’ current RDM competencies and rate the importance of these competencies.

Structured interviews were conducted, using close-ended and open-ended questions, covering research data lifecycle phases such as collection, storing, organization, documentation, processing, analysis, preservation, and data sharing.

The quantitative analysis of the respondents’ answers indicated a wide gap between doctoral students’ rated/self-rated current competencies and the rated importance of these competencies.

In conclusion, two major educational needs were identified in the qualitative analysis of the interviews: to improve and standardize data management planning, including awareness of the intellectual property and agreements issues affecting data processing and sharing; and to improve and standardize data documenting and describing, not only for the researcher themself but especially for data preservation, sharing, and re-using. Hence the study informs the development of RDM education for doctoral students.

URL : Doctoral Students’ Educational Needs in Research Data Management: Perceived Importance and Current Competencies

DOI : https://doi.org/10.2218/ijdc.v16i1.684