PCORI Announces Comment Period; Feedback Critical to Ensure Quality Research

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The Patient-Centered Outcomes Research Institute (PCORI) announced this week the public comment period for its landmark draft Methodology Report, which proposes standards for the conduct of patient-centered outcomes research.  While the draft report came out last month, the comment period closes on Friday, September 14, 2012.

The Personalized Medicine Coalition (PMC) has a long history with PCORI starting from when the legislation creating it was being drafted.  We advocated for recognition of personalized medicine in the conduct of comparative effectiveness research, which was incorporated into the legislation.  PMC’s methodology committee is charged with ensuring that the research funded by PCORI examines, among other things, research question responses based on patient molecular subgroup.

As part of the comment period announcement, PCORI stated that feedback received during the comment period would be reviewed for potential incorporation into a revised version of the report. The revised version will be considered for adoption by the PCORI Board of Governors at its November 2012 public meeting in Boston, Mass.  We have previously urged PCORI to be explicit in how the public comments are considered and incorporated. That, and other institutional development, is essential for the proper functioning of the organization.

The current report does not adequately address personalized medicine as an important factor in improving health outcomes through patient-centered outcomes research methodology. PMC will comment on the methodology report, and we urge our member organizations and others to do the same.  Active input from the community is required so that the research will live up to the high expectations that we have for it.

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