Data sharing and reanalysis of randomized controlled trials in leading biomedical journals with a full data sharing policy: survey of studies published in The BMJ and PLOS Medicine

Authors : Florian Naudet, Charlotte Sakarovitch, Perrine Janiaud, Ioana Cristea, Daniele Fanelli, David Moher, John P A Ioannidis

Objectives

To explore the effectiveness of data sharing by randomized controlled trials (RCTs) in journals with a full data sharing policy and to describe potential difficulties encountered in the process of performing reanalyses of the primary outcomes.

Design

Survey of published RCTs.

Setting

PubMed/Medline.

Eligibility criteria

RCTs that had been submitted and published by The BMJ and PLOS Medicine subsequent to the adoption of data sharing policies by these journals.

Main outcome measure

The primary outcome was data availability, defined as the eventual receipt of complete data with clear labelling. Primary outcomes were reanalyzed to assess to what extent studies were reproduced. Difficulties encountered were described.

Results

37 RCTs (21 from The BMJ and 16 from PLOS Medicine) published between 2013 and 2016 met the eligibility criteria. 17/37 (46%, 95% confidence interval 30% to 62%) satisfied the definition of data availability and 14 of the 17 (82%, 59% to 94%) were fully reproduced on all their primary outcomes. Of the remaining RCTs, errors were identified in two but reached similar conclusions and one paper did not provide enough information in the Methods section to reproduce the analyses. Difficulties identified included problems in contacting corresponding authors and lack of resources on their behalf in preparing the datasets. In addition, there was a range of different data sharing practices across study groups.

Conclusions

Data availability was not optimal in two journals with a strong policy for data sharing. When investigators shared data, most reanalyses largely reproduced the original results. Data sharing practices need to become more widespread and streamlined to allow meaningful reanalyses and reuse of data.

 

The development of a research data policy at Wageningen University & Research: best practices as a framework

Authors: Hilde van Zeeland, Jacquelijn Ringersma

The current case study describes the development of a Research Data Management policy at Wageningen University & Research, the Netherlands. To develop this policy, an analysis was carried out of existing frameworks and principles on data management (such as the FAIR principles), as well as of the data management practices in the organisation.

These practices were defined through interviews with research groups. Using criteria drawn from the existing frameworks and principles, certain research groups were identified as ‘best-practices’: cases where data management was meeting the most important data management criteria.

These best-practices were then used to inform the RDM policy. This approach shows how engagement with researchers can not only provide insight into their data management practices and needs, but directly inform new policy guidelines.

URL : The development of a research data policy at Wageningen University & Research: best practices as a framework

DOI : http://doi.org/10.18352/lq.10215

Standardising and harmonising research data policy in scholarly publishing

Authors : Iain Hrynaszkiewicz, Aliaksandr Birukou, Mathias Astell, Sowmya Swaminathan, Amye Kenall, Varsha Khodiyar

To address the complexities researchers face during publication, and the potential community-wide benefits of wider adoption of clear data policies, the publisher Springer Nature has developed a standardised, common framework for the research data policies of all its journals. An expert working group was convened to audit and identify common features of research data policies of the journals published by Springer Nature, where policies were present.

The group then consulted with approximately 30 editors, covering all research disciplines, within the organisation. The group also consulted with academic editors and librarians and funders, which informed development of the framework and the creation of supporting resources.

Four types of data policy were defined in recognition that some journals and research communities are more ready than others to adopt strong data policies. As of January 2017 more than 700 journals have adopted a standard policy and this number is growing weekly. To potentially enable standardisation and harmonisation of data policy across funders, institutions, repositories, societies and other publishers the policy framework was made available under a Creative Commons license.

However, the framework requires wider debate with these stakeholders and an Interest Group within the Research Data Alliance (RDA) has been formed to initiate this process.

This paper was presented at the 12th International Digital Curation Conference, Edinburgh, UK on 22 February 2017 and will be submitted to International Journal of Digital Curation.

URL : Standardising and harmonising research data policy in scholarly publishing

DOI : https://doi.org/10.1101/122929