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PCORI Grants Could Encourage Personalized Medicine-Focused CER

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Originally published Oct. 4.

The Patient-Centered Outcomes Research Institute last month announced it would award as much as $26 million in grants for 40 projects that help the institute establish methodologies for conducting comparative effectiveness research in healthcare.

In the first year, PCORI will provide up to $13 million in grant funding. Grant recipients can request up to $250,000 per year for two years. Letters of intent are due Nov. 1 and grant application must be received by PCORI on or before Dec. 1.

Created under the Patient Protection and Affordable Care Act of 2010, PCORI is a non-profit, non-governmental organization that aims to conduct research that patients, healthcare professionals, and payors can use to make more informed choices about medical treatments and preventative strategies. PCORI hopes that research comparing the quality and effectiveness of medical interventions will improve healthcare quality and reduce costs.

Whether personalized medicine strategies will feature prominently in CER conducted by PCORI has been an ongoing point of concern among personalized medicine stakeholders. While there are several personalized medicine advocates on PCORI's board of governors, none of the representatives in the institute's methodology committee are experts in the discipline. And although the integration of personalized medicine with CER has support in high places, such as National Institutes of Health Director Francis Collins, some fear that the CER mechanisms funded by the government will primarily support treatments for the general population.

PCORI's grant announcement lists several areas of interest that project proposals must fall under, some of which could encourage submissions focused on personalized medicine.

For example, PCORI is interested in proposals that seek to identify and evaluate patient-centered outcomes instruments. "This may include predictive tools (e.g., instruments that measure or predict outcomes of interest to patients) or identifying standards for measurement properties of patient-reported outcomes for use in comparative effectiveness research, across a variety of interventions and patient populations," PCORI informs in the grant announcement.

CER stands to advance personalized medicine adoption if research shows that treatments administered with the help of diagnostic tests to identify best responders can improve outcomes for a molecularly defined patient subset compared to the larger, undifferentiated disease population.

Another area in which PCORI is seeking submissions is for methods to identify gaps in comparative effectiveness knowledge as perceived by patients and healthcare providers.

"Of special interest are gaps that are particularly relevant to vulnerable populations, including, but not limited to, low-income populations; underserved minorities; children; the elderly; women; and people with disabilities, chronic, rare, and/or multiple medical conditions," PCORI notes. "Vulnerable populations" could conceivably also include molecularly defined patient subpopulations who have hard-to-treat illnesses and limited treatment options.

Eligible applicants for PCORI grants include higher education institutions, nonprofits, for-profit groups, government entities, foreign organizations who wish to conduct research that benefits the US healthcare system, and Native American tribal organizations.

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