PCORI Opens its Pocketbook

The Patient-Centered Outcomes Research Institute, or PCORI, announced last week that it will be granting a total of $12 million for up to 14 contracts for studies aimed at improving upon existing research methodologies to demonstrate clinical effectiveness. The improvements seek to benefit researchers, policy-makers, clinicians, caregivers and patients in making tough healthcare decisions by offering more efficient processes and stronger validation benchmarks for research studies conducted in the public and private sector.

The news coincides with PCORI’s fifth priority initiative, “Accelerating Patient-Centered Methodological Research,” under its National Priorities for Research and Research Agenda, and is the first of many program funding announcements. In total, PCORI projects that $427 million in research commitments will be made to vendors by the end of 2013. Non- and for-profit organizations, hospitals, academic institutions, laboratories and units of local and state government are encouraged to apply for grants by the deadline of March 13, 2013.

Areas that applicants are asked to focus on include methods for conduct of systematic reviews of patient-centered comparative effectiveness research topics, identifying optimal methods for engaging patients in the research process, and methods to enhance the reproducibility, transparency, and replication of patient-centered outcome research, among others.

In addition, PCORI also announced today that its Board of Governors adopted 47 revised Methodology Standards intended to steer the administration of sponsored research. These revised standards resulted from over 124 sets of public comments over a 54 day discussion period. PCORI’s Methodology Committee also came up with 62 recommendations for researchers with regard to Standards for Formulating Research Questions. Particular areas included patient centeredness, dissemination, research prioritization, general and crosscutting methods for all patient-centered outcome research, and specific design approaches.

These new Methodology Standards suggest that government and industry are moving toward common ground on just how to measure the effectiveness of clinical interventions relying on drugs. The big question is how these standards and the funding that accompanies them will shape the future direction of research…and whether that research will begin to drive bottom-line decisions on access and reimbursement.