Data Sharing at a Crossroads

Rockhold, Frank; Nisen, Perry; Freeman, Andrew

doi:10.1056/nejmp1608086

Cited by 57 publications

(64 citation statements)

References 4 publications

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“…15,16 Pharmaceutical industry associations have committed to making data more accessible, 17 and several data platforms are now available. 11,18–21 …”

mentioning

confidence: 99%

Clinical Trial Participants’ Views of the Risks and Benefits of Data Sharing

2018

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BACKGROUND Sharing of participant-level clinical trial data has potential benefits, but concerns about potential harms to research participants have led some pharmaceutical sponsors and investigators to urge caution. Little is known about clinical trial participants’ perceptions of the risks of data sharing. METHODS We conducted a structured survey of 771 current and recent participants from a diverse sample of clinical trials at three academic medical centers in the United States. Surveys were distributed by mail (350 completed surveys) and in clinic waiting rooms (421 completed surveys) (overall response rate, 79%). RESULTS Less than 8% of respondents felt that the potential negative consequences of data sharing outweighed the benefits. A total of 93% were very or somewhat likely to allow their own data to be shared with university scientists, and 82% were very or somewhat likely to share with scientists in for-profit companies. Willingness to share data did not vary appreciably with the purpose for which the data would be used, with the exception that fewer participants were willing to share their data for use in litigation. The respondents’ greatest concerns were that data sharing might make others less willing to enroll in clinical trials (37% very or somewhat concerned), that data would be used for marketing purposes (34%), or that data could be stolen (30%). Less concern was expressed about discrimination (22%) and exploitation of data for profit (20%). CONCLUSIONS In our study, few clinical trial participants had strong concerns about the risks of data sharing. Provided that adequate security safeguards were in place, most participants were willing to share their data for a wide range of uses. (Funded by the Greenwall Foundation.)

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“…15,16 Pharmaceutical industry associations have committed to making data more accessible, 17 and several data platforms are now available. 11,18–21 …”

mentioning

confidence: 99%

Clinical Trial Participants’ Views of the Risks and Benefits of Data Sharing

2018

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“…8 However, a more nuanced approach to increasing the availability of individual patient data may be required. For example, further work is needed to clarify what is meant by individual patient data and when and how different data types and different levels of granularity should be made available.…”

Section: Resultsmentioning

confidence: 99%

“…[6][7][8][9] However, many of the data sharing activities that are needed for trial transparency are not complex. We believe that trying to solve the complex issues around availability of individual patient data should not eclipse or distract from a more pressing problem: the unavailability of even summary data and protocols from all controlled trials.…”

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confidence: 99%

Focus on sharing individual patient data distracts from other ways of improving trial transparency

Hoffmann

Glasziou

Beller

et al. 2017

BMJ

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“…Instead of resisting this movement is many, researchers are now instead debating when and how data should be shared after publication of the primary manuscript. This is largely good news, but the unintended consequence of developing multiple approaches and systems will create a fragmented, complex, and confusing landscape in which the full benefits of data sharing will not be realized [5]. If we do not react this proliferation soon, we may be in the paradoxical position of disclosure without transparency.…”

Section: Moving Aheadmentioning

confidence: 99%

“…The imperative to share one's data would seem compelling, and the debate of how and when to do so has been active. This topic of data disclosure and transparency in clinical research has been the subject of many recent articles, editorials, policy statements, and indeed regulations over the past few years [1][2][3][4][5][6][7][8][9][10][11]. Of note in this list was the proposal by ICMJE in 2016 to require public disclosure of patient level data for articles published in their journals.…”

Section: Introductionmentioning

confidence: 99%

Statistical controversies in clinical research: data access and sharing—can we be more transparent about clinical research? Let’s do what’s right for patients

Rockhold

2017

Annals of Oncology

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Calls for greater transparency and 'open data access' in clinical research are widespread, from sources including the Executive Office of the President, which in 2013 called for increased access to the results of federally funded research. In 2015, The Institute of Medicine issued a report advocating for a multi-stakeholder effort to foster responsible data sharing, and there are many others. Open science is good for researchers, good for innovation, and good for patients. The question at the center of the open-science efforts for clinical trials should not be whether data should be shared, but rather how we can usher in responsible methods for doing so. Unfortunately, there remain numerous perceived barriers to complete transparency around clinical trial data. This paper reviews the current status of data disclosure, the barriers to achieving it and a suggestion for the future.

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Data Sharing at a Crossroads

Cited by 57 publications

References 4 publications

Clinical Trial Participants’ Views of the Risks and Benefits of Data Sharing

Clinical Trial Participants’ Views of the Risks and Benefits of Data Sharing

Focus on sharing individual patient data distracts from other ways of improving trial transparency

Statistical controversies in clinical research: data access and sharing—can we be more transparent about clinical research? Let’s do what’s right for patients

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