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Activity Number:
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105
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Type:
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Contributed
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Date/Time:
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Monday, July 30, 2007 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #309975 |
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Title:
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Estimate of Treatment Effect with Adjustment for Post-Discontinuation Treatment Resumption and Crossover and Other Therapies in Oncology Clinical Trials
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Author(s):
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Shengyan Hong*+ and Yanping Wang
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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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, Indianapolis, IN, 46285,
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Keywords:
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Treatment effect adjustment ; post-discontinuation therapy ; treatment resumption and crossover ; proportional hazards model ; oncology clinical trial
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Abstract:
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In oncology clinical trials of survival comparison between an experimental therapy and a best supportive care or an active control, it is clinical reality that many patients will receive additional therapies during post-discontinuation follow-up period. It is only natural to assume that the post-discontinuation therapies (PDTs) will have impact on patients' survival outcome and its effect should be adjusted for when estimating and comparing treatment effect. What makes this adjustment even more challenging is that some patients in one or both treatment arms could resume their assigned treatment or switch treatment as part of PDT. We propose a method to adjust for post-discontinuation treatment resumption and crossover as well as other therapies using Cox proportional hazards model approach. An example from a phase III clinical trial will be used to illustrate the proposed methodology.
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