For Immediate Release
Patient-Centered Outcomes Research Institute
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.
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.
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.
the trade-offs between long-term virologic response and adverse effects
associated with different regimens of new oral antiviral medications.
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
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
“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.
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.
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.
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.
Press release source: http://www.pcori.org/content/pcori-board-approves-providing-50-million-cer-hepatitis-c