More Research Volunteers Are Getting Their Medical Test Results. Should We Cheer — or Worry?

Kat McGowan | STAT | December 1, 2016

Volunteer for a clinical trial and your body will be poked, prodded, scanned, and analyzed. But you’re unlikely to get any of the results. A small but influential band of activists has been pushing hard to change that — and they’re starting to get traction. The research establishment has long opposed giving volunteers access to their data, even though that’s supposed to be part of the arrangement. Some worry that it’s too easy for laypeople to misinterpret test results, while others maintain that it’s a waste of resources to organize data for individual review.

But in a striking shift, two global drug makers recently agreed to let clinical trial participants review data generated by their own bodies. In July, the federal office that oversees research on human subjects recommended that data sharing be the rule, not the exception. And many of the million people expected to sign up for the big federal research project known as the Precision Medicine Initiative1 will get access to everything scientists learn about them, including DNA readouts and data on the billions of bacteria living in their guts.

“It’s a power shift,” said Dr. Eric Topol, a cardiologist and director of the Scripps Translational Science Institute. But it remains to be seen how the average volunteer will make use of the information — or if they will even want to see it. In two clinical trials for diabetes in 2013, Pfizer enabled US volunteers to set up online accounts where they could download data such as heart rhythm charts, lab reports, and vital sign measurements after the study’s end. Less than 15 percent did so...