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Activity Number:
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608
- Patient-Focused Clinical Trials: Challenges and Considerations for Trial Design, Endpoints, and Analysis
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Type:
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Topic Contributed
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Date/Time:
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Thursday, August 1, 2019 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #304788
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Presentation 1
Presentation 2
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Title:
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Patient-Focused Clinical Trials: Challenges and Considerations for Trial Design, Endpoints, and Analysis
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Author(s):
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Melanie Bell* and Mallorie H Fiero* and Stacie Hudgens* and Stephanie Manson*
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Companies:
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Clinical Outcomes Solutions and Novartis Oncology and University of Arizona and US Food and Drug Administration
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Keywords:
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Patient reported outcomes;
patient-centered;
trial design;
endpoint selection
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Abstract:
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Patient-centered drug development is encouraged by major regulatory agencies such as the EMA and FDA. Incorporating the patient perspective and experience as part of pharmaceutical product development and regulatory evaluation has become increasingly widespread, and patient-reported outcomes are frequently included in trials. The patient perspective can inform trial design, endpoint selection, and the analysis and interpretation of results. This panel will discuss challenges and considerations encountered in regulatory, industry, and academic settings when designing and evaluating patient-centered clinical trials.
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Authors who are presenting talks have a * after their name.
