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In Public Comments, PMC Asks PCORI to be More Specific About How CER and Personalized Rx Align

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Originally published March 20.

The Personalized Medicine Coalition has submitted comments to the Patient Centered Outcomes Research Institute urging the non-profit to be more specific in demonstrating how its comparative effectiveness research agenda will advance personalized medicine.

PCORI, an organization formed by the 2010 Patient Protection and Affordable Care Act, has issued a draft document outlining the research areas in which it wants to conduct studies comparing the safety and efficacy of medical interventions, healthcare delivery models, and infrastructure. The findings from such CER, PCORI hopes, will help drive informed healthcare decision making, improve patient outcomes, and reduce unnecessary spending in healthcare.

The deadline for the public to comment on PCORI's CER research priorities was March 15.

"The legislation that created PCORI requires the institute to align personalized medicine and CER and specifies procedures to assure that alignment," Amy Miller, PMC's Vice President for Public Policy, said in a statement. "As written, PCORI's draft research priorities are so vague and broad that it is impossible to say whether PCORI's work will support personalized medicine as Congress intended."

In written comments to PCORI, PMC made five recommendations, encouraging the institute to lay out a transparent process for obtaining stakeholder opinions and how this input will be used; to develop an expert advisory panel to align PCORI's CER with personalized medicine objectives; to improve CER by incorporating new information and technological innovations that help update evidence and fill information gaps; to develop both broad and specific research priorities; and to hire experts who have the scientific and clinical knowhow to evaluate a variety of research proposals and reward grants.

Earlier this month, PCORI held a meeting to gather public input on its CER priorities, after which stakeholders knowledgeable of the process questioned how closely personalized medicine strategies aligned with traditional CER objectives. Furthermore, as it stands, PCORI's research focus appears to be on advancing what it calls "patient-centered outcomes research." However, whether the definition of that term would necessarily align with personalized medicine strategies remains unclear (PGx Reporter 3/7/2012).

According to a preliminary definition from PCORI, "patient-centered outcomes research helps people make informed healthcare decisions and allows their voice to be heard in assessing the value of healthcare options."

Specifically, this type of research will assess the benefits and harms of medical interventions to inform decision making, focusing on the "comparisons and outcomes that matter to people," according to the working definition. Additionally, patient-centered research will also focus on a variety of settings and populations to "address individual differences and barriers to implementation and dissemination," the definition notes.

At a meeting of its Board of Governors on March 5, PCORI was slated to consider the draft definition of "patient-centered outcomes research."

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