Patient-reported outcomes supporting anticancer product approvals.


In 2006, the US Food and Drug Administration (FDA) published draft guidance to provide recommendations for development, validation, implementation, and interpretation of patient-reported outcome (PRO) measures that can support treatment benefit claims in product labeling. Here, we summarize and discuss FDA approvals of anticancer products in the context of… (More)


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@article{Rock2007PatientreportedOS, title={Patient-reported outcomes supporting anticancer product approvals.}, author={Edwin P. Rock and Dianne L Kennedy and Melissa H Furness and William F Pierce and Richard Pazdur and Laurie B. Burke}, journal={Journal of clinical oncology : official journal of the American Society of Clinical Oncology}, year={2007}, volume={25 32}, pages={5094-9} }