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Comment on the Proposed New and Revised PCORI Methodology Standards (2016)
- 1. Standards for Formulating Research Questions
- 10: Standards for Studies of Diagnostic Tests
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- 13: General Comments on the Proposed Revisions to the PCORI Methodology Standards
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- 9. Standards for Adaptive Trial Designs
- Peer-Review Process Comments (2014)
- Draft Methodology Report Public Comment Period (2012)
- Past Opportunities to Provide Input
For Immediate Release
Patient-Centered Outcomes Research Institute
WASHINGTON, D.C. (Dec. 8, 2014) — The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors today approved the development of a PCORI Funding Announcement (PFA) providing up to $50 million for up to four comparative clinical effectiveness research (CER) studies on the best ways to diagnose and treat hepatitis C virus infection.
The Board also approved the issuance of two PFAs totaling up to $150.7 million to support the second phase of development of PCORnet, PCORI’s initiative to improve the efficiency of health research nationwide by harnessing the power of data from electronic health records and other sources.
With the Board’s approval, PCORI will develop a PFA focused on hepatitis C virus (HCV) research questions that emerged as the highest priorities during a multi-stakeholder workshop PCORI hosted on October 17. The four priority topics are:
- Finding out which screening methods and testing strategies in which settings lead to the best detection rates.
- Assessing alternative ways to deliver care to high-risk populations.
- Exploring the trade-offs between long-term virologic response and adverse effects associated with different regimens of new oral antiviral medications.
- Comparing the benefits and harms of starting treatment immediately after a diagnosis versus active surveillance, in which treatment starts once a patient shows progression to liver disease or other manifestations of infection.
Hepatitis C affects more than 3 million people in the United States, the majority of whom are undiagnosed. About one-third of these individuals will develop chronic liver disease if untreated.
“HCV is a major health threat that can have devastating consequences for infected people and their families,” said PCORI Executive Director Joe Selby, MD, MPH. “Recently approved medications are immensely promising and offer vast improvements over previous therapies, but as yet there’s no ‘real-world’ evidence of their long-term effectiveness nor comparative evidence to help inform decisions about screening, diagnosis, and treatment of HCV.
“In response to the feedback we’ve received from many healthcare stakeholders, and with the approval of our Board, PCORI will issue a funding announcement in the next few months to support CER that will build the evidence needed to better inform practice and address questions important to patients,” Selby said.
PCORI also will issue two funding announcements later this month to support the next stage of PCORnet’s development, funding up to 13 of the Clinical Data Research Networks (CDRNs) and up to 22 of the Patient-Powered Research Networks (PPRNs) that make up PCORnet. PCORI will provide up to $8.75 million for each CDRN and up to $1.68 million for each PPRN over the three-year second phase of PCORnet’s development, which will begin in September 2015 at the end of the 18-month first phase. All of the 11 current CDRNs and 18 PPRNs are eligible to apply as are new networks that can meet the baseline requirements within six months of the beginning of Phase II.
In other business, the Board discussed PCORI’s proposed research strategy for the next five years. PCORI plans to continue to fund research under its broad funding announcements at a reduced level, and shift funding toward a smaller number of larger studies focused on specific high-priority topics. PCORI will make extended funding commitments to select topics and in some cases fund clusters of studies around a particular topic to produce more comprehensive findings that will have greater impact.
The strategy builds on PCORI’s previous investments and leverages the topic prioritization process facilitated by its six multi-stakeholder advisory panels. The plan also encourages research that will tap into PCORnet once it is fully operational.
Presentation materials and an archive of the webinar from today’s Board meeting are available on PCORI’s website.
The Patient-Centered Outcomes Research Institute (PCORI) is an independent, non-profit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work.
The Patient-Centered Outcomes Research Institute (PCORI) is an independent nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continually seeking input from a broad range of stakeholders to guide its work.
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