CER and Personalized Medicine: More Work to Be Done


I just got back from a meeting of the Board of Governors of the Patient-Centered Outcomes Research Institute in New York City. PCORI, as you probably know, is the independent Institute established by the health reform law to conduct comparative clinical effectiveness research. Regarding CER and personalized medicine, I’ll say now what I said late in late 2009: in the midst of the debate over health care reform — it remains to be seen whether CER will align with personalized medicine. CER that aligns with personalized medicine should be  patient-centered, because it will be structured to recognize and respect patient differences. 

We’ve made important progress toward that goal, with CER statute for the first time referencing genetics and individual patient difference.  I am hopeful we’ll  eventually get there, but we’re not there yet. Personalized medicine was, as far as I saw, mentioned only once during the PCORI Board meeting. NIH Director Francis Collins raised it during a discussion of the report from the PCORI Methodology Committee. Commenting on the Committee’s charter and the “perceived tension between CER and personalized medicine,” he said he “would hope that the Methodology Committee would take that on,” and suggested emphasizing alignment with personalized medicine and patient preferences in the document. I applaud Dr. Collins for raising this point, but we will need more voices joining him to make sure the Board and Methodology Committee to integrate CER and PM. It seems to reinforce some concerns expressed earlier by PMC about lack of an expert in genomics or personalized medicine on the Methodology Committee. The idea proposed by PMC of creating an advisory panel on personalized medicine and innovation could be one step to help ensure alignment between CER and personalized medicine.
One of the big news items from the PCORI Board meeting was the appointment of Dr. Joe Selby as the PCORI Executive Director. I was heartened by Dr. Selby’s comments at the meeting, in which he stressed the importance of hearing from, and focusing on, patients. It will be equally important for Dr. Selby and the additional staff he hires to understand that part of the Institute’s charge from Congress is to account for genomics and subpopulation differences. Failure to do so will prevent us from realizing the potential for personalized medicine to improve health care quality and value. 

The next meeting of the PCORI Board of Governors is in Washington, D.C. on July 18 and 19th. I hope you’ll join me there in support of comparative clinical effectiveness research that is centered on patient needs and aligned with personalized medicine.

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