Patient Perspectives on Data Sharing

While understanding of patient perspectives about participating in research is growing, particularly with regard to consent, disclosure, and non-disclosure of research activities, little is known about trial participant’ views on data sharing. Although pressure is increasing from journal editors, research sponsors, and patient groups for more sharing of participant-level data, concerns about privacy and informed consent are often invoked as reasons to limit the amount of sharing (Godlee and Groves 2012; Institute of Medicine (U.S.) and Institute of Medicine (U.S.) 2015; Krumholz et al. 2016; Taichman et al. 2016).

One recent study surveyed clinical trial participants at 3 major institutions about their perspectives regarding the risks and benefits of sharing participant-level data (Mello et al. 2018). Most participants believed the benefits of data sharing outweighed the potential negatives and were willing to share their data regardless of the intended use (i.e., for research by drug companies and/or academic institutions) with the exception of use for litigation purposes.

It is worth noting that this study surveyed patients in explanatory clinical trials who had consented to participate and who were recruited by their physician. For an ePCT that involves a waiver of consent, participant views on data sharing might be very different. As expressed earlier in this chapter, healthcare system leaders have strong opinions about sharing data from ePCTs, and individual participants might also.  Additionally, the findings of the study by Mello et al are in contrast to a previous report on participant views regarding sharing EHR data. In this case, participants cared most about the potential uses of the shared information and were substantially less willing to share with for-profit pharmaceutical and device companies than with academic researchers (Grande et al. 2013). As another example of how participant views might vary depending on study type, in a survey of patients regarding participating in quality improvement initiatives, approximately half felt comfortable with data sharing as long as they were not able to be individually identified (Kaplan et al. 2016).

More work is needed to understand participant views on data sharing from ePCTs. Even though we do not have a full understanding of patient perspectives, the demand for data sharing continues to accelerate.

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REFERENCES

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Godlee F, Groves T. 2012. The New BMJ Policy on Sharing Data from Drug and Device Trials. BMJ 345: e7888–e7888. https://doi.org/10.1136/bmj.e7888. PMID: 23169872.

Grande D, Mitra N, Shah A, et al. 2013. Public Preferences about Secondary Uses of Electronic Health Information. JAMA Intern Med. 173: 1798–1806. https://doi.org/10.1001/jamainternmed.2013.9166. PMID: 23958803.

Institute of Medicine (U.S.), and Institute of Medicine (U.S.), eds. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, D.C: National Academies Press. DOI: 10.17226/18998. PMID: 25590113.

Kaplan SH, Gombosev A, Fireman S, et al. 2016. The patient’s perspective on the need for informed consent for minimal risk studies: Development of a survey-based measure. AJOB Empirical Bioethics. 7:116–124. doi:10.1080/23294515.2016.1161672.

Krumholz HM, Terry SF, Waldstreicher J. 2016. Data Acquisition, Curation, and Use for a Continuously Learning Health System. JAMA. 316: 1669–70. https://doi.org/10.1001/jama.2016.12537.P MID: 27668668.

Mello MM, Lieou V, Goodman SN. 2018. Clinical Trial Participants’ Views of the Risks and Benefits of Data Sharing. NEJM. 378: 2202–11. https://doi.org/10.1056/NEJMsa1713258. PMID: 29874542 .

NIH Data Sharing Policy and Implementation Guidance March 5, 2003 Version. n.d. Accessed February 10, 2015. http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm.

Taichman DB, Backus J, Baethge C, et al. 2016. Sharing Clinical Trial Data: A Proposal From the International Committee of Medical Journal Editors. Ann Intern Med. 164: 505. https://doi.org/10.7326/M15-2928. PMID: 26792258.


Version History

Published December 16, 2018.

Citation:

Data Sharing and Embedded Research: Patient Perspectives on Data Sharing. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: https://rethinkingclinicaltrials.org/chapters/dissemination/data-share-top/patient-perspectives-on-data-sharing/. Updated January 4, 2019. DOI: 10.28929/103.