Patient Reported Outcomes (PRO) in the Spotlight as a Cancer Moonshot Priority

Among the 10 ambitious priorities a blue ribbon panel forwarded to the Cancer Moonshot Task Force, headed by Vice President Biden, the call for accelerated research to identify approaches to monitor and manage patient-reported symptoms and other patient-reported outcomes (PRO) brings this topic further prominence. This echoes a central theme at this year’s ASCO Annual Meeting, and the focus of an Executive Roundtable held during the meeting on patient-strategies for oncology research and treatment.

It may be surprising that symptom management and the use of PRO in cancer care hasn’t received more attention over the years, given that cancer is a disease of symptoms. Both disease symptoms (pain, fatigue, shortness of breath and loss of weight, among others) and toxicities of treatment have a disproportionate impact on the experience of someone with cancer relative to most other medical conditions. To date, clinical care and drug research have focused far more on outcomes like tumor growth or shrinkage, biomarkers, and measures of overall or progression-free survival, when in fact we are learning that patients may be willing to trade some measure of traditional outcome for relief from treatment-related symptoms, like fatigue, that would improve their quality of life.

As the 2016 CancerCare Patient Access and Engagement Report found, there is an “impact gap” in communication between patients and their clinical care teams. The survey found that in discussions with care providers, about half of patients downplayed their side effects and symptoms. Nearly 40% did not report symptoms or side effects because they did not want to “bother” their doctors. Making symptoms management a higher priority in the clinical encounter would facilitate these conversations between patients and the care team, in both directions.

It is incumbent on clinical development researchers to consider how best to measure the impact of new therapy on outcomes that matter to patients in order to support the overall Value assessment of the drug under study. This will require expertise in selecting appropriate, valid measures of relevant symptoms. Furthermore, regulatory agencies are increasingly engaging with multiple stakeholders to support consideration of the voice of the patient in their decisions.

The spotlight that’s being shone on this issue – and the potential research and implementation funding that may ensue – couldn’t come at a more pivotal moment for cancer research and treatment.

By Joe O’Connell, M.D., Vice President and Global Therapeutic Lead, Medical Affairs, inVentiv Health

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