This statistic is stunning. Of all SWOG Cancer Research Network’s phase III treatment trials activated since 2015, a whopping 89 percent included patient-reported outcomes (PROs). Examples? Well, we have Dr. Ken Grossmann’s S1404 high risk melanoma trial, Dr. Rob Svatek’s 1602 bladder cancer trial, and Dr. Alex Herrera’s S1826, a lymphoma trial that just launched this month. Lung-MAP, our lung cancer precision medicine trial, also contains PROs.

Not to mention, nearly all SWOG population science trials routinely use PROs as their primary or key secondary endpoints.

Since arriving on the scene decades ago, PROs are now routine. That’s because they’re useful, and they benefit our patients. By allowing us to systematically track how trial participants function and feel during the study, PROs improve the symptom and quality of life data we collect. This is critical to getting meaningful trial results and truly evaluating new treatments. For example, aromatase inhibitors were approved before routine use of PROs – and we and our patients were largely unprepared for the severe joint pain that patients with breast cancer endure when taking the drugs.

Just as PROs are meant to systematically and accurately capture the patient experience, here at SWOG we want to ensure we’re systematically and accurately capturing PROs. That’s why we have established a PRO Core at our statistics and data management center, a new initiative included in our recent NCORP Research Base grant request to the National Cancer Institute.

The goal of the core is creating consistency and speed as we develop these sub-studies, as well as helping us manage the data they generate, and analyze results. Personnel in the core include Drs. Joseph Unger, Dawn Hershman, Lynn Henry, Mike Fisch, and Gary Lyman, with Dr. Riha Vaidya at the stats center coordinating the effort. Given the exploding use of PROs in our trials, a goal of the core is to manage the resources available for PRO studies efficiently and effectively.

Core members provide both scientific oversight and input in the PRO design, to ensure rigor and to ensure that these sub-studies are conducted according to SWOG standards. They also oversee the logistics of managing PRO data. Successful use of PROs requires adherence to key design and analysis principles – and core members ensure this happens. In March, Joe Unger was lead author on a paper in Urologic Oncology on PROs, and he laid out those design and analysis principles, which are so necessary for the accuracy, validity, and feasibility of our work. He also neatly sums up the value of PROs and how NCI has responded to them:

“PROs that assess symptoms and QOL are critical to newly planned clinical trials. The value of PROs is recognized by the NCI through its support of QOL scientific committees, its promulgation of an electronic PRO platform, and its development of patient-reported toxicity ratings. As even advanced cancer patients live longer, a patient-centered approach to evaluating investigational treatments with PROs has become increasingly important.”

He adds: “In the modern treatment era, how well patients live with their cancer is an increasingly important issue. This has to be measured well, and PROs allow us to do that.”

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