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Keyword Search Criteria: patient-reported outcome returned 6 record(s)
Tuesday, 07/31/2018
Completion Rates and Considerations for Analyses of Patient-Reported Outcomes in Open-Label Cancer Trials: FDA Review of Trials, 2007 - 2017
Jessica K. Roydhouse, Office of Hematology and Oncology Products, US Food and Drug Administration; Mallorie H. Fiero, Office of Biostatistics, US Food and Drug Administration; Bellinda King-Kallimanis, Office of Hematology and Oncology Products, US Food and Drug Administration; Paul G. Kluetz, Oncology Center of Excellence, US Food and Drug Administration


Wednesday, 08/01/2018
Analysis of Multiple Thresholds in a Responder Analysis of Patient-Reported Outcome Measures
Lysbeth Floden, Clinical Outcome Solutions; Melanie L Bell, University of Arizona; Stacie Hudgens, Clinical Outcome Solutions


Single Item Analysis of Patient-Reported Outcome Measures in a Phase III Randomized Controlled Trial
Stacie Hudgens, Clinical Outcome Solutions; Lysbeth Floden, Clinical Outcome Solutions


Single Item Analysis of Patient-Reported Outcome Measures in a Phase III Randomized Controlled Trial
Stacie Hudgens, Clinical Outcome Solutions; Lysbeth Floden, Clinical Outcome Solutions
9:00 AM

Analysis of Multiple Thresholds in a Responder Analysis of Patient-Reported Outcome Measures
Lysbeth Floden, Clinical Outcome Solutions; Melanie L Bell, University of Arizona; Stacie Hudgens, Clinical Outcome Solutions
9:45 AM

Opportunities of Using Real World Data to Inform Regulatory Considerations for Medical Devices
Martin Ho, FDA
2:25 PM