American health & drug benefits
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Am Health Drug Benefits · Jun 2016
Patient-Reported Outcomes in Oncology Drug Labeling in the United States: A Framework for Navigating Early Challenges.
Despite an increased use of patient-reported outcomes (PROs) in oncology clinical trials, integrating the patient perspective into drug approval decisions and documentation has been challenging. ⋯ PRO data collected in clinical trials should be used in drug development to evaluate the drug's efficacy; it is encouraging that US regulators are willing to work with drug sponsors to overcome the challenges associated with the development, implementation, and interpretation of PROs. The tools discussed in this article can facilitate the planning process for oncology researchers, as well as assist in communicating with US regulators.