Patient Power!…Patient Power?

One of the most intriguing aspects of translational science and medicine is the rapid emergence of patient reported outcomes as a priority in biomedical research.  Of course, the most striking efforts are those underway by Patient-Centered Outcomes Research Institute (PCORI) that are fast out of the gate with truly impressive goals and budgets.  

I had the honor of attending several workshops this past autumn on patient-centered outcomes, one of which was hosted by IOM on PCORI, and the energy and excitement were real, as was the list of questions and concerns.  Are patient reported outcomes credible evidence?  How will we deal with all this dirty data?  How can we do research this way?  Can patient reported data ever be used directly as or to support regulatory evidence?

These are all interesting questions but, as a data scientist, I don’t think the answers are difficult to attain.  When data changes the science must change or at least adapt.  It will not and cannot be a matter of trying to cleanse all data to meet a specific standard,  it simply is what it is…and it is relevant.  This ‘dirty data’ is the new science.  Does filling out pages of an FDA adverse event form make the event more real than the same story told thru the MedWatcher mobile app?  The FDA does not think so.  The agency is working hard to adapt and we scientists and physicians must do the same.  Like most data types and scientific approaches, patient-reported outcome research is neither pandora or panacea.  Hopefully, it is just the next useful tool in a very difficult struggle against complex diseases.

A friend who happens to also be a physician reminded me recently that one of the most fundamental parts of being a doctor is asking your patient how they are feeling.  I think he is a very wise man although I am loath to ever tell him so.

What do you think about patient reported outcomes?

Eric Perakslis is Associate Editor for Novel Communication for DIA’s Therapeutic Innovation & Regulatory Science journal. Eric is the Executive Director of the Center for Biomedical Informatics and the Countway Library of Medicine at Harvard Medical School. Eric was most recently the CIO and Chief Scientist (Informatics) at the U.S. Food and Drug Administration. Prior to FDA, Eric was Senior Vice President of R&D IT at J&J Pharmaceuticals R&D. Eric also held the posts of Vice President R&D Informatics, Vice President and CIO, Director of Research IT, Assistant Director and Director of Drug Discovery Research at J&J.

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One Response to Patient Power!…Patient Power?

  1. Eric, I could not agree with you more! Another great example of how “patient power” is changing biomedical research can be found on the research page of PatientsLikeMe that includes citations for the more than 30 papers that have been published using data from the site. PRO is one more tool in the toolbox, but in time perhaps it will be the essential tape measure without which progress cannot be made.

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