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

For Immediate Release:

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.


The draft guidance we’re releasing today is intended to improve the quality and consistency of data in order to inform patients with cancer about the symptoms and impacts they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

Additional Information

  • Today, the U.S. Food and Drug Administration issued a draft guidance document, “Core Patient-Reported Outcomes in Cancer Clinical Trials,” which, when finalized, will provide recommendations to sponsors on which patient-reported outcomes (PRO) concepts to measure in cancer clinical trials.
  • The draft guidance addresses how to incorporate assessment of PRO in clinical trials of drugs and biological products that are intended to support product labeling describing anti-tumor (preventing or inhibiting the formation or growth of tumors) activity in patients with cancer.
  • The draft guidance also addresses the frequency of these PRO assessments within cancer trials, highlighting that PRO assessments should be of sufficient frequency to take into account the administration schedule of the products being studied. It also discusses labeling considerations for PROs submitted with oncology product applications.

Related Information

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


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