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The Patient-Centered Outcomes Research Institute (PCORI) is launching new programs that are expected to encourage more analysis of the effectiveness of specific drugs and medical products, while also building infrastructure that could support clinical research on biopharmaceutical products. Since it was established by the 2010 health reform legislation, PCORI has devoted much of its resources and energy to building institutional infrastructure and capacity for evaluating research proposals, for establishing standards for comparative effectiveness research (CER), and for communicating the results of funded research. Now, with its annual budget expanding to $650 million this year, PCORI executive director Joe Selby says that the Institute is poised to invest more in assessing and comparing important medical products and procedures.
One initiative is PCORI’s “pragmatic clinical trials” program, which is slated to fund a handful of large simple studies designed to determine the risks, benefits, and costs of an intervention as used in clinical practice under real-life conditions. PCORI plans to award up to $15 million to support six-to-nine projects that will run for three-to-five years, and compare at least two approaches considered effective in treating a clinical conditions, including drugs, devices and medical procedures. The plan is to answer important research questions that don’t lend themselves to analysis in randomized clinical trials or larger observational studies. More broadly, these longer-term studies will produce meaningful outcomes on mortality, functional status, quality of life and general symptoms. Letters of intent are due in March, and full applications in August.
New research network