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      Predictors of clinical trial data sharing: exploratory analysis of a cross-sectional survey

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          Abstract

          Background

          A number of research funders, biomedical journals, pharmaceutical companies, and regulatory agencies have adopted policies advocating or mandating that clinical trialists share data with external investigators. We therefore sought to determine whether certain characteristics of trialists or their trials are associated with more unfavorable perceptions of data sharing. To date, no prior research has addressed this issue.

          Methods

          We conducted an exploratory analysis of responses to a cross-sectional, web-based survey. The survey sample consisted of trialists who were corresponding authors of clinical trials published in 2010 or 2011 in one of six general medical journals with the highest impact factors in 2011. The following key characteristics were examined: trialists’ academic productivity and geographic location, trial funding source and size, and the journal in which it was published. Main outcome measures included: support for data sharing in principle, concerns with data sharing through repositories, and reasons for granting or denying requests. Chi-squared tests and Fisher’s exact tests were used to assess statistical significance.

          Results

          Of 683 potential respondents, 317 completed the survey (response rate 46%). Both support for data sharing and reporting of specific concerns with sharing data through repositories exceeded 75%, but neither differed by trialist or trial characteristics. However, there were some significant differences in explicit reasons to share or withhold data. Respondents located in Western Europe more frequently indicated they have or would share data in order to receive academic benefits or recognition when compared with respondents located in the United States or Canada (58 versus 31%). In addition, respondents who were the most academically productive less frequently indicated they have or would withhold data in order to protect research subjects when compared with less academically productive respondents (24 versus 40%), as did respondents who received industry funding when compared with those who had not (24 versus 43%).

          Conclusions

          Respondents indicated strong support for data sharing overall. There were few notable differences in how trialists viewed the benefits and risks of data sharing when categorized by trialists’ academic productivity and geographic location, trial funding source and size, and the journal in which it was published.

          Electronic supplementary material

          The online version of this article (doi:10.1186/1745-6215-15-384) contains supplementary material, which is available to authorized users.

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          Most cited references44

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          Sharing Detailed Research Data Is Associated with Increased Citation Rate

          Background Sharing research data provides benefit to the general scientific community, but the benefit is less obvious for the investigator who makes his or her data available. Principal Findings We examined the citation history of 85 cancer microarray clinical trial publications with respect to the availability of their data. The 48% of trials with publicly available microarray data received 85% of the aggregate citations. Publicly available data was significantly (p = 0.006) associated with a 69% increase in citations, independently of journal impact factor, date of publication, and author country of origin using linear regression. Significance This correlation between publicly available data and increased literature impact may further motivate investigators to share their detailed research data.
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            Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors.

            To examine the extent and nature of outcome reporting bias in a broad cohort of published randomised trials. Retrospective review of publications and follow up survey of authors. Cohort All journal articles of randomised trials indexed in PubMed whose primary publication appeared in December 2000. Prevalence of incompletely reported outcomes per trial; reasons for not reporting outcomes; association between completeness of reporting and statistical significance. 519 trials with 553 publications and 10,557 outcomes were identified. Survey responders (response rate 69%) provided information on unreported outcomes but were often unreliable--for 32% of those who denied the existence of such outcomes there was evidence to the contrary in their publications. On average, over 20% of the outcomes measured in a parallel group trial were incompletely reported. Within a trial, such outcomes had a higher odds of being statistically non-significant compared with fully reported outcomes (odds ratio 2.0 (95% confidence interval 1.6 to 2.7) for efficacy outcomes; 1.9 (1.1 to 3.5) for harm outcomes). The most commonly reported reasons for omitting efficacy outcomes included space constraints, lack of clinical importance, and lack of statistical significance. Incomplete reporting of outcomes within published articles of randomised trials is common and is associated with statistical non-significance. The medical literature therefore represents a selective and biased subset of study outcomes, and trial protocols should be made publicly available.
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              Public Availability of Published Research Data in High-Impact Journals

              Background There is increasing interest to make primary data from published research publicly available. We aimed to assess the current status of making research data available in highly-cited journals across the scientific literature. Methods and Results We reviewed the first 10 original research papers of 2009 published in the 50 original research journals with the highest impact factor. For each journal we documented the policies related to public availability and sharing of data. Of the 50 journals, 44 (88%) had a statement in their instructions to authors related to public availability and sharing of data. However, there was wide variation in journal requirements, ranging from requiring the sharing of all primary data related to the research to just including a statement in the published manuscript that data can be available on request. Of the 500 assessed papers, 149 (30%) were not subject to any data availability policy. Of the remaining 351 papers that were covered by some data availability policy, 208 papers (59%) did not fully adhere to the data availability instructions of the journals they were published in, most commonly (73%) by not publicly depositing microarray data. The other 143 papers that adhered to the data availability instructions did so by publicly depositing only the specific data type as required, making a statement of willingness to share, or actually sharing all the primary data. Overall, only 47 papers (9%) deposited full primary raw data online. None of the 149 papers not subject to data availability policies made their full primary data publicly available. Conclusion A substantial proportion of original research papers published in high-impact journals are either not subject to any data availability policies, or do not adhere to the data availability instructions in their respective journals. This empiric evaluation highlights opportunities for improvement.
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                Author and article information

                Contributors
                vinay.rathi@yale.edu
                kelly.strait@yale.edu
                cary.gross@yale.edu
                hrynaszkiewicz@nature.com
                joffes@upenn.edu
                harlan.krumholz@yale.edu
                kristina.dzara@yale.edu
                joseph.ross@yale.edu
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                2 October 2014
                2 October 2014
                2014
                : 15
                : 1
                : 384
                Affiliations
                [ ]Yale University School of Medicine, 333 Cedar Street, New Haven, CT 06510 USA
                [ ]Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, 1 Church Street, Suite 200, New Haven, CT 06510 USA
                [ ]Section of General Internal Medicine and the Robert Wood Johnson Foundation Clinical Scholars Program, Department of Medicine, Yale University School of Medicine, P.O. Box 208093, New Haven, CT 06520 USA
                [ ]Nature Publishing Group, The Macmillan Building, 4 Crinan St, London, N1 9XW UK
                [ ]Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, 3401 Market Street, Suite 320, Philadelphia, PA 19104 USA
                [ ]Section of Cardiovascular Medicine and the Robert Wood Johnson Foundation Clinical Scholars Program, Department of Medicine, Yale University School of Medicine, P.O. Box 208088, New Haven, CT 06520 USA
                [ ]Department of Health Policy and Management, Yale University School of Public Health, P.O. Box 208034, New Haven, CT 06520 USA
                Article
                2249
                10.1186/1745-6215-15-384
                4192345
                25277128
                795d0c25-e76b-4ce1-8e09-a05107ea6dde
                © Rathi et al.; licensee BioMed Central Ltd. 2014

                This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 19 December 2013
                : 22 September 2014
                Categories
                Research
                Custom metadata
                © The Author(s) 2014

                Medicine
                data sharing,clinical trial,data repository
                Medicine
                data sharing, clinical trial, data repository

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