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Activity Number:
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500
- Beyond Randomized Studies: Nonrandomized, Single Arm, or Special Studies
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 2, 2017 : 10:30 AM to 12:20 PM
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Sponsor:
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Section on Medical Devices and Diagnostics
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Abstract #324171
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View Presentation
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Title:
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Biomarker Based Study Design with Multiple Single Arms
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Author(s):
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Shiling Ruan*
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Companies:
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Novartis
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Keywords:
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Biomarker ;
Non-randomized ;
Study design
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Abstract:
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Randomized and well-controlled clinical trials provide a reliable level of evidence for the evaluation of new devices and drugs, but it also has its limitations. Such designs might not always be realistic or sometimes could lead to large sample size and expose a large population of patients to unnecessary treatments. The rapid development of biomarkers and biomarker-based algorithms offer opportunities for better patient selection and treatment allocation. However, it also presents new challenges for clinical trial designs in the assessment of clinical utility for companion diagnostic devices, as well as in the evaluation of new investigational treatments. This talk will discuss the non-randomized biomarker based design with a focus on multiple single arm studies. Examples of the assessment of clinical utility of a biomarker and the evaluation of a new drug will be discussed.
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Authors who are presenting talks have a * after their name.
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