July 13, 2018: Clinical Trial Data Sharing: Perspectives from Participants and PCORI (Michelle M. Mello, JD, PhD, Steven Goodman, MD, MHS, PhD)


Michelle M. Mello, JD, PhD
Professor of Law, Stanford Law School
Professor of Health Research and Policy, Stanford University School of Medicine

Steven Goodman, MD, MHS, PhD
Associate Dean, Clinical and Translational Research
Professor of Medicine and Health Research and Policy
Stanford University School of Medicine
Vice-chair, PCORI Methodology Committee


Clinical Trial Data Sharing: Perspectives from Participants and PCORI


Clinical research; Data sharing; Data metrics; Patient-Centered Outcomes Research Institute; PCORI; Patient participation; Patient perspective

Key Points

  • The presenters conducted a study that explored patients’ perspectives on being included in clinical trials. The study aimed to understand how patients feel about being part of trials and potential risks associated with the use of their clinical data.
  • Results from the study are published in “Clinical Trial Participants’ Views of the Risks and Benefits of Data Sharing” in the New England Journal of Medicine.
  • The majority of participants indicated that potential health benefits for their children or themselves is their primary reason for their clinical trial participation.
  • The majority of participants view the benefits of data sharing as greatly outweighing the potential risks.

Discussion Themes

The distinction between anonymous and de-identified data is an important one. Many people do not know what de-identified means and lack understanding that it is different from data being anonymous.

Data linkage is key in achieving data longevity. It would be interesting to extend some of the findings to better understand how the average American understands how their data could potentially be reused.

While the results of this study are not generalizable to those not actively participating in clinical trials, it is important to note that historical data have shown that most people prefer being asked to use their data for research purposes.



@Collaboratory1, @MichelleM_Mello, @goodmanmetrics, @NEJM, #clinicaltrial, #datasharing, #pctGR