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The Front Line
The Front Line: Charles D. Blanke, MD, SWOG Chair

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PCORI Trial (And Others!) Signal New Partnership Era

Dec. 4, 2015 - Early next year, SWOG will activate S1415CD. It's a historic clinical trial for us. It's our first funded entirely by the Patient-Centered Outcomes Research Institute, or PCORI, the non-profit created by Congress in 2010 to promote evidence-based, patient-focused healthcare research.

A $7.75 million, five-year PCORI contract supports S1415CD without supplementation from the National Cancer Institute. Dr. Scott Ramsey and Dr. Gary Lyman, both of Fred Hutch, oversee the trial in collaboration with Dr. Dawn Hershman of Columbia University Medical Center, Dr. Sean Sullivan of the University of Washington, and Dr. William Barlow of Cancer Research And Biostatistics.

The trial is a pragmatic one, and will test whether a guidelines-based, standing-order entry system for the use of colony-stimulating factors (CSFs) is more effective than usual clinical care. The trial tackles a big issue for patients receiving chemotherapy, and for the doctors who care for them. We all know CSFs are not that easy to use properly. Doctors widely under- and over-prescribe them. In fact, research shows CSF use is inconsistent with guidelines 55 to 95 percent of the time, putting our patients at risk.

S1415CD is unique in many ways, including the composition of its study team. An External Stakeholder Advisory Group that includes patients, oncologists, insurance plan leaders, policy makers, NCORP investigators and an ethicist, helped design the trial. The group will continue to play an active role throughout and following the trial, providing input on study recruitment, implementation, interpretation, and dissemination of results.

Collaboration and partnerships underpin our future. This is increasingly being emphasized as a goal of the NCTN. Our partners provide both funding and the scientific input needed to do inventive, rigorous, and relevant cancer research.

We will increasingly be partnering with ASCO, including the potential to co-manage a Latin America clinical trials workshop. Next year, three SWOG member sites -- the Carolinas HealthCare System, the Cancer Research Consortium of West Michigan, and the Michigan Cancer Research Consortium -- will launch the TAPUR study, the first clinical trial directly sponsored by ASCO. Other partnerships familiar to you are ongoing. SWOG researchers now work regularly with basic scientists at Cold Spring Harbor and The Jackson Laboratory. And with our landmark Lung-MAP trial, we're partnering with NCI, the Friends of Cancer Research, and the Foundation for the National Institutes of Health.

Partnering can be challenging. We sometimes follow different procedures and hear different opinions. Compromise, not a new concept for researchers, is occasionally necessary. And we may need to cede some control of operations and budgeting. But SWOG and I truly believe partnering can be deeply rewarding. Working with others often allows us to ask bigger, bolder questions -- important for our continued success.

SWOG NCORP sites interested in taking part in S1415CD can visit SWOG.org to download an FAQ and other materials, and attend a webinar to be held Tuesday, January 12th from 9-10 am PST, or 12-1 pm EST. Dial in information will be provided on SWOG.org, or email kwatabay@fredhutch.org.