Abstract Details
Activity Number:
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646
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Type:
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Contributed
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Date/Time:
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Thursday, August 7, 2014 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #312942
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View Presentation
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Title:
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Assessing the Impact of Nonproportional Hazards on Estimation of Treatment Effects of Progression-Free Survival
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Author(s):
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Adam Boyd*+ and David Raunig
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Companies:
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Array BioPharma and ICON Medical Imaging
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Keywords:
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survival analysis ;
interval censoring ;
oncology
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Abstract:
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The majority (18 / 29, 62%) of recent FDA regulatory submissions leading to approval of drugs to treat solid tumors were based on progression-free survival (PFS) or other tumor-based, interval-censored endpoints (Huang et al, DIJ, 2012). In randomized studies with time-to-event endpoints such as PFS, it is common to compare treatments using the log-rank test, and to summarize treatment effect estimates via the hazard ratio as estimated from the proportional hazards model. In most cases, the fact that the data are interval-censored is ignored and right-censoring methods are applied, usually by imputing the right-most point of the time interval as the progression date ("right-point imputation"). In this paper we investigate the impact of non-proportional hazards (NPH) on estimation and testing of the hazard ratio using the proportional hazards model when the data are interval censored and right-point imputation is applied. Robustness properties of other approaches, such as Finkelstein's method, are also explored. Recommendations for estimation in the presence of NPH are provided.
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Authors who are presenting talks have a * after their name.
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