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  1. Oncology Center of Excellence

Patient-Focused Drug Development

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Twitter: #OCEPFDD

The Oncology Center of Excellence (OCE) Patient-Focused Drug Development (PFDD) program fosters collaboration between FDA Centers and external stakeholders involved in patient outcomes research in cancer populations. 

Cancer patients experience disease symptoms and symptomatic treatment side effects that can impact their ability to function and other aspects of their health-related quality of life. The PFDD Program identifies rigorous methods to assess the patient experience which complements existing survival and tumor information to provide additional evidence about the effects of cancer therapies on patients.

The program focuses on three key areas:

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In 2021, the OCE along with CDER and CBER published a guidance for industry providing recommendations for the collection of a core set of patient-reported clinical outcomes in cancer clinical trials and related considerations for instrument selection and trial design: “Core Patient-Reported Outcomes in Cancer Clinical Trials.” 

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