Abstract Details
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Activity Number:
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13
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Type:
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Topic Contributed
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Date/Time:
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Sunday, August 3, 2014 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #311662
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View Presentation
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Title:
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Impact of Scan-Frequency and Over-Enrollment in Cancer Trials: A Statistician's View
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Author(s):
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Ram Suresh*+
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Companies:
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GlaxoSmithKline
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Keywords:
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median estimation ;
over-enrollment ;
scan-frequencies
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Abstract:
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Cancer trials present unique challenges. Typical trial designs based on proportional hazards assumption, targeting a specified number of events, do not adequately account for the impact of the frequency, timing of tumor assessments, and enrollment. Certain tumor scan-frequencies, while not having a huge influence on the power of the study could have a profound impact on statistical estimation. In addition, over-enrollment could result in under-estimation of the survival-medians while not impacting the power of the study. These statistical issues and potential solutions will be discussed using real registration trials in solid tumors.
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Authors who are presenting talks have a * after their name.
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