National Pharmaceutical Council Comments on PCORI Approval of Research Methodology Standards

For Immediate Release
Contact: Andrea Hofelich, 202-827-2078,

Washington, DC (November 19, 2012)—The National Pharmaceutical Council (NPC) today commented on the Patient-Centered Outcomes Research Institute’s (PCORI) revised methodology standards, which are intended to set the groundwork for the research methods used to develop comparative effectiveness research (CER). PCORI voted to approve revisions to the standards during its board of governors meeting today.

“NPC looks forward to closely reviewing the revisions to the standards in the methodology committee report. With the billions of dollars in public and private funds being spent on comparative effectiveness research, it is more important than ever to produce high-quality research that can be used by patients and their providers to make informed decisions about their health care treatments. Using sound, rigorous research methods can help us meet that goal,” said NPC President Dan Leonard.

The PCORI report is intended to set minimum standards for research, allowing for future changes. NPC suggested that future versions include improving stakeholder input and transparency, identifying what works best for individual patients, and ensuring the use of a broad range of research designs and methods.

“As we learn more over time, research methods will continue to evolve and improve. We hope that PCORI will incorporate new research methods and learnings in future versions of this report,” said Leonard.

NPC has a longstanding focus on research methods, and has been collaborating with other organizations on projects such as setting best practice principles for CER, developing high-quality principles  for observational studies (also known as the GRACE principles), creating tools to help end-users interpret CER findings, and determining how to account for individual treatment effects in CER, among others topics.

“NPC and our member companies welcome the opportunity to work with PCORI and to continue the dialogue to further advance research standards,” said Leonard.


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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An upcoming conference, The Myth of Average—Why Individual Patient Differences Matter, will explore the role and challenges of individual treatment effects, or heterogeneity, in developing treatment recommendations, practice guidelines, and coverage and reimbursement policies for patients. The conference will take place Friday, November 30 at the Omni Shoreham Hotel in Washington, DC. It is being sponsored by the National Pharmaceutical Council, the National Health Council and WellPoint, as well as 17 other patient, provider and health care organizations. Keynote speakers include Joe Selby, MD, MPH, Executive Director, Patient Centered Outcomes Research Institute (PCORI) and Patrick Conway, MD, MsC, Chief Medical Officer, Centers for Medicare and Medicaid Services (CMS) & Director, Office of Clinical Standards and Quality. The is no charge to attend. Register online at