FDA Provides Guidance on Measuring Patient-Reported Outcomes in Cancer Clinical Trials

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WASHINGTON, D.C. — The following quote is attributed to Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research:

“Patients would like to better understand symptoms they may experience and how a cancer therapy can affect their quality of life. One way to accomplish this is to ask patients in clinical trials about the severity of their symptoms and ability to function using rigorously developed patient-reported outcomes. However, achieving sufficient consistency and quality of these data in cancer drug applications submitted to the FDA has been a challenge.

“The FDA’s Oncology Center of Excellence has undertaken a sustained effort to identify methods to rigorously collect patient-reported outcomes in cancer clinical trials. We’ve been engaging with patients and outcomes research experts through a series of public workshops and publications on which outcomes to measure, how frequently to assess them and the tools available to do so.

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“The draft guidance we’re releasing today is intended to improve the quality and consistency of data in order to inform patients with cancer about the symptoms and impacts they may experience during treatment with a cancer therapy.”

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