NPC Comments on the PCORI Methodology Report

(Washington, DC, November 20, 2013)—The National Pharmaceutical Council today commented on the Patient-Centered Outcomes Research Institute’s (PCORI) methodology report, which is intended to set basic standards for the conduct of patient-centered outcomes research, or comparative effectiveness research (CER). The PCORI Methodology Report was approved by the PCORI board of governors on Monday.

“We’re pleased to see that the report addresses issues that NPC had raised previously:  ensuring the use of a broad range of research designs and methods, identifying what works best for individual patients, and acknowledging the need to develop practical tools that can be incorporated into practice,” said NPC President Dan Leonard.

“It’s notable that PCORI included a section that recognizes the importance of not only studying the health benefits for a population, but accounting for individual treatment effects as part of that process as well,” said Mr. Leonard. “What works best for many patients may not work best for all patients, so this research could help to fill those gaps in information.”

NPC has a longstanding focus on research methods, along with developing and disseminating practical tools to guide researchers and health care stakeholders in their decision-making processes.  In recent years, NPC has collaborated with other organizations on projects such as developing tools to aid researchers and others in identifying high-quality observational studies (also known as the GRACE checklist), creating tools to help end-users interpret CER findings, collaborating on usability criteria to make research useful and meaningful for patient care, setting best practice principles for CER, and assisting researchers and decision-makers in determining how to account for individual treatment effects, among other topics. Additionally, NPC, working with the Academy of Managed Care Pharmacy and the International Society for Pharmacoeconomics and Outcomes Research as part of the CER Collaborative, recently launched a set of online tools ( to assist health care decision-makers in evaluating evidence and using this evidence to inform formulary and coverage decisions.

“We look forward to sharing information with PCORI about NPC’s ongoing research and dissemination efforts that may inform future research methods reports,” added NPC Chief Science Officer Dr. Robert Dubois. “Our work will compare and contrast the various standards and guidelines for conducting observational studies, will identify areas for future methods development and consensus building, and may inform future research standards.”

About the National Pharmaceutical Council

The National Pharmaceutical Council is a health policy research organization dedicated to the advancement of good evidence and science, and to fostering an environment in the United States that supports medical innovation. Founded in 1953 and supported by the nation’s major research-based pharmaceutical companies, NPC focuses on research development, information dissemination, and education on the critical issues of evidence, innovation and the value of medicines for patients. For more information, visit and follow NPC on Twitter @npcnow.

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