Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors

Taichman, Darren B.; Sahni, Peush; Pinborg, Anja; Peiperl, Larry; Lainé, Christine; James, Astrid; Hong, Sung Tae; Haileamlak, Abraham; Gollogly, Laragh; Godlee, Fiona; Frizelle, Frank; Florenzano, Fernando; Drazen, Jeffrey M.; Bauchner, Howard; Baethge, Christopher; Backus, Joyce

doi:10.3346/jkms.2017.32.7.1051

Cited by 70 publications

(93 citation statements)

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“…Researchers now increasingly recognize the benefits of considering data sharing from the beginning of their projects, including when they obtain consent from participants and ensure confidentiality when data are shared (see Sarpatwari et al 2014;El Emam et al 2015), and they detail publication plans to make the best use of databases (Drazen 2014). And medical journal editors have taken steps to make data sharing the norm for some types of studies, as even they recently recognized that mandated sharing can be problematic and flexibility is needed (see Taichman et al 2017). These developments certainly move toward more informed and efficient data sharing, but until efforts are made to better protect those who would share data, it is ill-advised to move hastily toward policies limiting publication to authors who share.…”

Section: Rationales For Not Compelling Authors To Share Their Datamentioning

confidence: 99%

“…Others pressure authors to deposit their data by requiring them to explicitly state why they are not sharing and requiring authors to have compelling reasons for not sharing (see Barbui et al 2016). In some disciplines, editors have grouped together and agreed to move toward mandated data sharing for some types of data (see Taichman et al 2017). These developments lead editors in some fields, such as medicine, to view the practice of data sharing, in one form or another, as inevitable (Merson et al 2016;Bauchner et al 2016).…”

Section: The Journal's Position On Data Sharingmentioning

confidence: 99%

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Data Sharing Mandates, Developmental Science, and Responsibly Supporting Authors

Levesque

2017

J Youth Adolescence

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Data sharing has come of age. Long expected as a professional courtesy but rarely honored, data sharing is now highlighted in codes of ethics, supported by research communities, required by leading funding organizations, and variously encouraged and mandated by journals and even publishers. These developments reveal how sharing generates many benefits, all of which go to the integrity of the scientific process. Yet, sharing remains a complex phenomenon. This Editorial explains the journal's response to the publisher's mandate to establish an appropriate data sharing policy for the Journal of Youth and Adolescence. It describes the need to balance the benefits of sharing with its costs for authors publishing in multidisciplinary, developmental science journals like this one. For this journal and at this time, that balance leads us to err on the side of caution, which means supporting those who created their data and not coercing public sharing as a condition for publishing. This approach recognizes authors' reliance on a wide variety of data, the needs of differentially situated authors, the requirements of robust peer review, and the potential harms that can come from editors' unilateral sharing mandates.

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Section: Rationales For Not Compelling Authors To Share Their Datamentioning

confidence: 99%

Section: The Journal's Position On Data Sharingmentioning

confidence: 99%

Data Sharing Mandates, Developmental Science, and Responsibly Supporting Authors

Levesque

2017

J Youth Adolescence

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“…Specifically, DUAs address important issues such as limitations on date usage, obligations to data safeguard, liability for harm arising from data usage and publication, and privacy rights that are associated with transfer of confidential or protected data. In contrast, the U.S. Office for Human Research Protections stated that there is no need for separate consent from trial participants for the sharing of de-identified data [4].…”

Section: Potential Drawbacks From Data Sharingmentioning

confidence: 99%

“…In addition, the emergence of data sharing as a potential requirement by some agencies and journals warrants attention by the imaging community. Indeed, from July 1st, 2018 the International Committee of Medical Journal Editors (ICMJE) will require a data sharing statement as a condition of consideration for publication of clinical trials [4].…”

Section: Introductionmentioning

confidence: 99%

To share or not to share? Expected pros and cons of data sharing in radiological research

et al. 2018

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The aims of this paper are to illustrate the trend towards data sharing, i.e. the regulated availability of the original patientlevel data obtained during a study, and to discuss the expected advantages (pros) and disadvantages (cons) of data sharing in radiological research. Expected pros include the potential for verification of original results with alternative or supplementary analyses (including estimation of reproducibility), advancement of knowledge by providing new results by testing new hypotheses (not explored by the original authors) on preexisting databases, larger scale analyses based on individualpatient data, enhanced multidisciplinary cooperation, reduced publication of false studies, improved clinical practice, and reduced cost and time for clinical research. Expected cons are outlined as the risk that the original authors could not exploit the entire potential of the data they obtained, possible failures in patients' privacy protection, technical barriers such as the lack of standard formats, and possible data misinterpretation. Finally, open issues regarding data ownership, the role of individual patients, advocacy groups and funding institutions in decision making about sharing of data and images are discussed. Key Points• Regulated availability of patient-level data of published clinical studies (data-sharing) is expected.• Expected benefits include verification/advancement of knowledge, reduced cost/time of research, clinical improvement.• Potential drawbacks include faults in patients' identity protection and data misinterpretation.

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“…An excellent model is the individual patient data meta-analyses of the ProCESS, ARISE, and ProMISe trials of early, goal-directed therapy for septic shock [14]. This is becoming more pressing than ever before, as data sharing plans are now mandated in RCTs [15].…”

mentioning

confidence: 99%

A critical view on primary and secondary outcome measures in nutrition trials

Arabi

Preiser

2017

Intensive Care Med

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Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors

Cited by 70 publications

References 1 publication

Data Sharing Mandates, Developmental Science, and Responsibly Supporting Authors

Data Sharing Mandates, Developmental Science, and Responsibly Supporting Authors

To share or not to share? Expected pros and cons of data sharing in radiological research

A critical view on primary and secondary outcome measures in nutrition trials

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