PCORI approves funding for hepatitis C research

The Patient-Centered Outcomes Research Institute (PCORI) recently approved funding for up to four large studies comparing different approaches to treating hepatitis C. The institute also approved funding for phase II of National Patient-Centered Clinical Research Network (PCORnet). 

The budget for the hepatitis C studies will be $50 million, with a maximum of $20 million for any one study. The approvals came during the organization’s Board of Governors meeting in Washington on Monday.

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PCORnet is a resource for supporting multicenter and multisite research in comparative effectiveness research. Phase I was a development period, with PCORI working with networks that originated in healthcare systems (clinical data research networks) and networks concerned with a particular disease or condition that are run by groups of patients and their families (patient-powered research networks).

The basic network structure of PCORnet funded under phase I will continue in phase II. PCORnet will have a projected capacity of up to 15 clinical trials and 40 observational studies, according to Rachael Fleurence, PhD, program director for CER Methods and Infrastructure.

The meeting also included a discussion of PCORI’s five-year research funding strategy. The organization expects to conduct fewer, larger clinical studies with more emphasis on trials that directly compare healthcare options or that are intended to fill evidence gaps. “This proposed funding strategy is the continuing evolution of our shift to larger, targeted, more stakeholder-based patient-centered outcomes research,” Christine Goertz, DC, PhD, chair of PCORI’s Science Oversight Committee.

In October, PCORI identified four key areas for further study:

· Determining which strategies work best to detect hepatitis C.

· Comparing intermediate care management to more intensive, integrated care management in chronic hepatitis C patients at high risk of nonadherence.

· Determining the trade-offs between long-term response and adverse effects for new regimens of antiviral medications such as sofosbuvir and ledipasvir.

· Comparing the benefits and harms of starting treatment immediately compared to active surveillance in newly diagnosed hepatitis C patients who are at low risk of progressive liver disease.