Keywords
Data-sharing, real-world data, observational
This article is included in the Research on Research, Policy & Culture gateway.
Data-sharing, real-world data, observational
In response to the reviewer's comments we have expanded the Methods to include a precision calculation, edited the Results to more accurately reflect what was done and expanded the Conclusion to talk about future work that is needed to assess the impact of journal data sharing requirements.
See the authors' detailed response to the review by Robin E. Champieux
Over the recent years, a number of articles and movements have called for the sharing of clinical trial data1–3. However the access to and sharing of real-world/observational data receives little and arguably insufficient attention. In this study we sought to assess the current state of data sharing in published observational studies in a general medical journal, namely the British Medical Journal (BMJ). The BMJ was chosen as the journal does not enforce a commitment of data sharing for observational studies4, but all research articles are required to contain a data sharing statement5.
All observational research articles published in the BMJ between 1st January 2015 and 31st August 2017 were investigated. These dates were chosen as it provides over 100 articles for analysis and recent data post-dating some of the articles regarding clinical trial data sharing2. Assuming a proportion of articles not being shared of between 20–40%, 100 articles would enable a precision of 7.8 to 9.6%. Observational research articles were defined as cohort, case-control and cross-sectional studies, as well as case series. Meta-analyses, systematic reviews, randomised controlled trials and genetic/Mendelian randomisation studies were excluded. The data sharing statements of these studies were reviewed. If the statement written was “no additional data available”5 or that data was not publicly available, the study data was classed as not shared. Statements alluding to data being available from the corresponding author, or a referral to access policies of the data source the study data was classed as shared. Where statements alluded to code or technical appendix being available, but no reference to data specifically being available, the study data was classed as not shared.
Two hundred and thirty seven observational studies were included. A review of the data sharing statements of these studies revealed that 149 (63%) studies did not share data.
In our review of the data sharing statements of observational studies published in the BMJ, we identified that the majority of studies did not share data. Whilst there are likely many reasons for this, including patient confidentiality concerns and the access possibilities of the data source, the lack of data sharing in observational research is a potential cause for concern. The key limitation of our study was the scope of the data. We only reviewed the data sharing statements of one medical journal and therefore the generalisability of our results is unclear. The data sharing policy of the BMJ is relatively general (sharing is encouraged, but specific requirements are not communicated). Follow on work should assess how the robustness of a journal’s data sharing policy could influence the rate of data sharing. Our analysis should be seen as exploratory rather than definitive. Further studies are needed, in greater depth, to confirm or refute our findings. If consistent findings are seen, the lack of sharing of observational research data is an area that warrants further attention.
Dataset 1: Raw data showing the studies identified from the BMJ and whether the data sharing statements indicated data was not/were available. doi, 10.5256/f1000research.12673.d1778716
LM and SR are employees of Bristol-Myers Squibb Company. AS, AS, SG and RW are employees of Evidera Inc.
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Competing Interests: No competing interests were disclosed.
Is the work clearly and accurately presented and does it cite the current literature?
Yes
Is the study design appropriate and is the work technically sound?
Yes
Are sufficient details of methods and analysis provided to allow replication by others?
Yes
If applicable, is the statistical analysis and its interpretation appropriate?
Partly
Are all the source data underlying the results available to ensure full reproducibility?
Yes
Are the conclusions drawn adequately supported by the results?
Yes
Competing Interests: No competing interests were disclosed.
Is the work clearly and accurately presented and does it cite the current literature?
Yes
Is the study design appropriate and is the work technically sound?
Yes
Are sufficient details of methods and analysis provided to allow replication by others?
Yes
If applicable, is the statistical analysis and its interpretation appropriate?
Not applicable
Are all the source data underlying the results available to ensure full reproducibility?
Yes
Are the conclusions drawn adequately supported by the results?
Yes
Competing Interests: No competing interests were disclosed.
Alongside their report, reviewers assign a status to the article:
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Version 2 (revision) 06 Nov 17 |
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Version 1 19 Sep 17 |
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