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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 - #309967 |
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Title:
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Censored Data Within Phase III Oncology Studies Using Independent Radiology Review (IRC) Assessments
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Author(s):
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Pralay Mukhopadhyay*+ and Thomas Kelleher
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Companies:
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Bristol-Myers Squibb Company and Bristol-Myers Squibb Company
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Address:
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5 Research Pkwy, Wallingford, CT, 06460,
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Keywords:
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IRC ; censoring ; discordance ; power
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Abstract:
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Use of IRC determined assessments are common in oncology trials where the primary endpoint is progression free survival (PFS). In such studies disagreement between the study investigator and the IRC assessments of tumor progression may occur. When a patient comes off study due to an investigator based progression which the IRC disagrees with, progressions by IRC are censored. However contribution to PFS as a death event may occur which can bias the estimates of the medians and impact the overall results. Several methods of analysis to address this discordance will be explored through simulation studies.
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