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Activity Number:
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280
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Type:
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Contributed
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Date/Time:
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Tuesday, August 4, 2009 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #303845 |
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Title:
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Validity and Utility of a Novel Method for Assessing Benefit-Risk Tradeoff in Clinical Trials
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Author(s):
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Maksim Pashkevich*+ and Nathan Enas
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Companies:
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Eli Lilly and Company and Eli Lilly and Company
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Address:
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Lilly Corporate Center, Indianapolis , IN, 46285,
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Keywords:
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Quality of life ; Statistical modeling ; Clinical trials ; Oncology
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Abstract:
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We propose a new method (BRASS) for assessing benefit-risk tradeoff longitudinally in clinical trials that relies on both patient's and physician's perspectives on treatment-related efficacy and harm. The questionnaire consists of only three questions answered on a visual analog scale. Data from a randomized Phase 2 oncology clinical trial are used to assess validity of the instrument as well as to evaluate its predictive utility. The latter is done by jointly modeling longitudinal tumor size and quality-of-life measurements (BRASS or a standard lung cancer instrument FACT-L), drug exposure, and survival. In addition to being simple to implement in a clinical trial, results indicate that BRASS appears valid, is predictive of patient's survival, and is consistent with FACT-L. The findings are encouraging for performing formal validation of BRASS in future clinical trials.
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