Also Approves New Funding Announcements on Opioid Treatment, Multiple Sclerosis
WASHINGTON, DC (Sept. 28, 2015) — The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors today approved $83 million to fund 26 patient-centered, comparative clinical effectiveness research (CER) studies on a range of conditions and patient populations.
Two of the new awards totaling $29.5 million will support studies on caring for people infected with hepatitis C virus (HCV). In addition, awards totaling nearly $7.4 million will fund research on rare conditions in response to PCORI’s offer of a special pool of funding to support rare disease research.
The HCV awards arose from a targeted funding opportunity PCORI issued in response to input from the healthcare community, which identified HCV infection as a top health concern. They focus on research questions that emerged as among the highest priorities during a multi-stakeholder workshop PCORI hosted last October. The newly approved CER studies will compare the trade-offs between different regimens of new oral antiviral medications and different ways to enhance HCV treatment adherence among injection drug users. Additional proposals submitted to this funding opportunity remain under consideration.
New oral medications for HCV offer significant improvements over previous therapies, but they were tested in specialized settings with carefully selected groups of patients. There is very little “real-world” evidence available of their long-term effectiveness in a wider range of patients and no comparative evidence to help inform care decisions.
“We heard from many people—including individuals with hepatitis C as well as clinicians who treat them, the pharmaceutical industry, payers, and others—that with the great promise offered by new antiviral medications, there are also many questions about hepatitis C therapies and care delivery that need to be answered,” said PCORI Executive Director Joe Selby, MD, MPH. “As the availability and use of the new antiviral medications increases, we’re pleased to support patient-centered CER that will help clinical decision makers to make better-informed choices about hepatitis C treatment and care.”
Each of the HCV studies will involve national advocacy organizations, major professional associations, payers, or other key patient and stakeholder groups in their research design and implementation.
The Board also approved 24 other awards, totaling nearly $53.6 million, under funding announcements issued in February under PCORI’s five National Priorities for Research. The CER studies on rare conditions will focus on comparing treatments for urea cycle disorders, genetic disorders caused by the liver’s inability to break down ammonia; non-cystic fibrosis bronchiectasis, a rare lung disease; and syringomyelia, a debilitating neurological condition.
Other CER studies will compare different options for arthritis, diabetes, multiple sclerosis, ductal carcinoma in situ (DCIS), tobacco addiction, end-stage renal disease, and rare conditions. Several will concentrate on the needs of particular populations, such as racial and ethnic minorities, low-income individuals, children, and other population groups. Details on the newly approved studies are available at pcori.org/research-results.
With these new awards, PCORI has approved $1.18 billion in funding for 468 patient-centered outcomes research projects, and the infrastructure and methods to support them, since it began funding research in 2012. All of the new awards were approved by the Board pending completion of a business programmatic review by PCORI staff and issuance of a formal award contract.
PCORI aims to issue new funding announcements this fall on MS care and long-term opioid treatment for chronic pain. PCORI will offer up to $50 million for CER to answer questions about the comparative effectiveness of different disease-modifying therapies for patients with MS and whether telehealth is as effective as conventional direct care.
PCORI will provide up to $40 million for CER to assess the effectiveness of strategies for reducing or discontinuing opioid use while managing chronic pain and of strategies to limit dose escalation. More details on these upcoming opportunities can be found in the Upcoming Opportunities page at pcori.org/funding-opportunities.
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.