Improved PCORI Infrastructure Needed to Deliver on Personalized CER Mandate


As I mentioned previously, the Patient-Centered Outcomes Research Institute (PCORI) issued its draft research priorities earlier this year.  The Personalized Medicine Coalition (PMC) provided comments on the draft that outline how PCORI must address fundamental structural issues to meet Congressional intent.  Specifically, the intent is that the research overseen and conducted by PCORI should support personalized medicine and align comparative effectiveness research with personalized medicine.

In the public comments on the draft research priorities, PMC offered five recommendations, outlining how PCORI can build the infrastructure needed to execute its mission as Congress intended:

 1.  Define a public engagement process: PCORI should outline a transparent process for obtaining input from all stakeholders, including patients, clinical experts and scientists, and detail how stakeholder input will be used. One possibility is to assemble all comments in a document and demonstrate how they informed the final draft.

 2. Establish a personalized medicine expert advisory panel: PCORI has the statutory authority to create expert advisory panels, on any topic, to carry out its mission. To assist PCORI with assuring that its work supports personalized medicine, PMC strongly requests that PCORI develop an expert advisory panel devoted to personalized medicine. As an educational organization dedicated to advancing the field and populated by stakeholders from all sectors of the health care universe, the PMC Clinical Science Committee offers its assistance in identifying potential members for this proposed expert advisory panel.

 3. Improve the science behind comparative effectiveness research (CER): One of PCORI’s Congressionally mandated tasks is to improve the quality of CER by incorporating new information and technological innovations into its studies, reviewing and updating the evidence as necessary and identifying future research that is needed to address information gaps. PMC suggests creating the infrastructure (and the processes) to achieve this goal now as the foundations of the organization are being established.

4. Make the research priorities more specific: The PCORI draft research priorities envisioned by statute were broad, encompassing all aspects of the health care system that relate to high-quality, effective patient care–and specific, calling for a transparent process to identify and prioritize research topics based on explicit criteria and public input. PMC strongly suggests that PCORI’s materials address the second point, assuming that the statute envisions a broad scope of research.

 5. Develop in-house capacity to engage broad scientific and clinical expertise: The mission of PCORI is unique and to carry it out PCORI must call on the capacity of a unique set of individuals to develop calls for research proposals, evaluate them, make awards, follow the progress of the research, and engage the public at all steps in the process. Having this infrastructure “in-house” is a necessary step in the Institute’s development.

We look forward to working with PCORI on these initiatives to strengthen its research agenda and infrastructure.  Personalized CER has great potential to elevate the quality of care in the United States and we are ready to do our part.

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