Developing and improving the science and methods of patient-centered comparative clinical effectiveness research (CER) is a central part of PCORI’s work. Better methods will produce more valid, trustworthy, and useful information that will lead to better healthcare decisions and, ultimately, to improved patient outcomes.
Methodology Standards
PCORI's Methodology Committee, in accordance with PCORI’s authorizing law, submitted to the Board of Governors on May 10, 2012, the first draft PCORI Methodology Report. After a 54-day public comment period, the report’s draft Methodology Standards were revised and adopted by the Board on November 19, 2012, then published on December 14, 2012. At its November 18, 2013, meeting, the Board of Governors approved minor editorial revisions to the standards.
Since then, the Board has adopted a major revision to the standards (May 2017) and along with 24 additional standards, including standards for research designs using clusters (May 2017); standards for data management plans and studies of complex interventions (April 2018); standards for qualitative methods, mixed methods research, and individual participant-level data meta-analysis (February 2019); and standards for usual care as a comparator (March 2024).
PCORI considers the accomplishment of developing, refining, and finalizing these standards to be a critical step in advancing the conduct of patient-centered CER. We look forward to working with our many stakeholders to see that these standards become a useful and valued resource for the entire healthcare community. Proposed studies are required to adhere to relevant PCORI methodology standards, as updated in 2019. We recognize that a variety of study designs and analytic methods may contribute valid new knowledge. If a proposed study uses an approach or methods not covered by those standards, it should adhere to other currently accepted best practices.
Methodology Report
During its November 18, 2013, meeting, PCORI’s Board of Governors accepted the report presented by PCORI’s Methodology Committee, which was revised to address extensive feedback received from the healthcare community during a public comment period that followed the July 2012 release of a draft.
On May 8, 2017, the PCORI Board of Governors adopted a major revision of our methodology standards, including the addition of a 12th category of standards, and an updated version of the Methodology Report was released in July 2017. On April 30, 2018, the Board of Governors adopted an additional six standards; an update to the Methodology Report was released in January 2019.
Articles of Interest
Getting the Methods Right — The Foundation of Patient-Centered Outcomes Research
Sherine E. Gabriel, M.D., and Sharon-Lise T. Normand, Ph.D., New England Journal of Medicine, Aug. 30, 2012.
Toward Patient-Centered Drug Development in Oncology
Ethan Basch, MD, New England Journal of Medicine, Aug. 1, 2013.
Posted: September 2013; Updated: April 2024
