Compliance Corner – News Round Up

June 29th, 2017 by Sharon L Nelson, MSN, RN, CNS, CIP, Executive Director, Consulting and Compliance Services

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This month we continue to contemplate big data as we look at two New England Journal of Medicine Perspective pieces.

In Bridging the Data-Sharing Divide – Seeing the Devil in the Details, Not the Other Camp, Dr. Lisa Rosenbaum reflects on the differing views of data-sharing evidenced at a recent NEJM-sponsored summit, during which clinical trialists and data scientists viewed data-sharing through divergent lenses. Among the concerns of clinical trialists are the years invested in data-gathering, the analysis of complex data, the pursuit to publish and the extra costs associated with data-sharing; after so much work to collect the initial data, clinical trialists may find data-sharing threatening, particularly when the concern of diminished funding for randomized clinical trials is factored in. Data scientists, however, contend that data-sharing can accelerate scientific progress and see unpublished negative studies as “missed learning opportunities and invitations to wasteful repetition of trials.”

Rosenbaum points out data-sharing appears inevitable – organizations like NIH, Cancer Moonshot, the Gates Foundation, and the Wellcome Trust now require grant applicants “to outline a data-sharing plan,” and the International Committee of Medical Journal Editors (ICMJE), which includes the NEJM, will in 2018 begin requiring a data sharing statement for all manuscripts submitted to ICMJE journals. We might conclude that the issue is not whether to share but how best to share. The challenge lies in moving past the polarization of the opposing views to a position Rosenbaum describes as openness “to one another’s experience and expertise, setting aside ideology in pursuit of more objective truths.”

To learn more about the opposing camps’ positions, read here.



“Patients want their data shared quickly, especially to ensure that other patients know about possible side effects.” In her Perspective piece Whose Data Are They Anyway? Can a Patient Perspective Advance the Data-Sharing Debate?, Dr. Charlotte Haug shifts the focus from clinical trialists and data scientists to the patients who participated in the NEJM data-sharing summit. According to Haug, patients want:

  • their data shared quickly to advance knowledge of side effects
  • control over how data are shared
  • trial results shared with and explained to participants themselves

Prompted by the patients’ revelations, Haug explores “who owns and should control clinical trial data.” Providing a brief overview of the 20th century evolution of human subject protections, particularly voluntary consent, Haug describes the different approaches U.S. and European legislators have taken on this data ownership question. Does consent mean the individual patient conveys the data property rights to researchers? Or that “patients own the data and give researchers license to use them for a defined purpose“?

Haug suggests that the data-sharing debate has been primarily between clinical trialists and data scientists, with neither camp spending much time exploring patient interests. Feedback from patients and patient advocates present at the NEJM summit, however, paints a picture of individuals “engage[d] in their own care, interact[ing] with clinicians and fellow patients, creat[ing] new knowledge, and suggest[ing] new ways of delivering health care.”

Explore here more patient views and Dr. Haug’s argument.



And, because we know you like to read, we’re passing along the STAT prime list of 27 Best Health and Science Books to Read This Summer, as recommended by notable figures, STAT staff and STAT readers. I’m definitely adding a few of these to my summer reading list.

We wish you a healthy dose of lazy, hazy days of summer, a cool breeze, a good book, and renewal.