A research team, led by Scott Ramsey, director of the Hutchinson Institute for Cancer Outcomes Research (HICOR), that includes UW Department of Pharmacy’s Pharmaceutical Outcomes Research and Policy Program (PORPP) faculty members Sean Sullivan, Jeannine McCune, Aasthaa Bansal, and Gary Lyman, who also serves as a co-director at HICOR, has been approved for a $7.75 million, four-year funding award by the Patient-Centered Outcomes Research Institute, or PCORI, an independent, nonprofit organization based in Washington, D.C. The award will be used to conduct a pragmatic clinical trial evaluating the use of colony stimulating factor to reduce the risk of serious infection in patients undergoing chemotherapy for breast, colorectal or lung cancer.
The study, titled “A Pragmatic Trial to Improve Colony Stimulating Factor Use in Cancer,” is one of five awards totaling $64.1 million approved by PCORI on Tuesday, Feb. 24, that aim to provide patients with information that will help them make better-informed decisions about their care. The result of conducting this important intervention study could lead to improved quality of life for individuals with breast, lung, and colorectal cancer. It is also one of the first studies selected for funding through PCORI’s Pragmatic Clinical Studies Initiative, an effort to produce results that are broadly applicable to a greater variety of patients and care situations and can be more quickly taken up in routine clinical practice.
This work will not only impact the profession of pharmacy, but also provide substantive benefit to cancer patients. This trial will evaluate if the use of colony stimulating factors, abbreviated CSFs, can be improved by using a clinical guideline-informed approach implemented by pharmacists. Appropriate use of the CSFs decrease cancer patients’ risk of experiencing low neutrophil, which fight off infection, counts and also decrease how often cancer patients experience a fever and a low neutrophil count (called febrile neutropenia), which can be life threatening. CSFs are expensive, for the patient and at a national level. Unfortunately, the CSFs have not been used according to clinical guidelines. This work seeks to conduct a large-scale pragmatic trial to compare outcomes of the CSFs – filgrastim and pegfilgrastim – in cancer patients with select solid tumors, comparing outcomes in those patients receiving CSFs according to the guideline-informed pharmacist-implemented system compared to typical clinical practice.
Many clinical studies test whether a treatment works under optimized conditions in specialized research centers, but health care is rarely delivered in such idealized situations and settings. Pragmatic clinical studies test a treatment’s effectiveness in “real-life” practice situations, such as typical hospital and outpatient care settings, and also can include a wider range of study participants, which potentially makes their findings more generally applicable.
“This project was selected for PCORI funding not only for its scientific merit and commitment to engaging patients and other healthcare stakeholders in a major study conducted in real-world settings, but also for its potential to answer an important question about the use of colony stimulating factors and fill a crucial evidence gap,” said PCORI Executive Director Joe Selby, MD, MPH. “We look forward to following the study’s progress and working with Fred Hutch and the University of Washington to share the results.”
The HICOR/PORPP study and the other projects approved for PCORI funding were selected through a highly competitive review process in which patients, caregivers, and other stakeholders joined scientists to evaluate the proposals. Applications were assessed for scientific merit, how well they will engage patients and other stakeholders, and their methodological rigor among other criteria.
Ramsey’s award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.
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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. For more information about PCORI’s funding awards, visit the Research and Results page on www.pcori.org. http://www.pcori.org/funding/opportunities
An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first and largest cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. For more information visit www.fredhutch.org or follow Fred Hutch on Facebook, Twitter or YouTube.