Abstract Details
Activity Number:
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26
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Type:
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Topic Contributed
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Date/Time:
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Sunday, August 4, 2013 : 2:00 PM to 3:50 PM
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Sponsor:
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Section on Statistics in Imaging
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Abstract - #309310 |
Title:
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A Simulation Study to Evaluate Accuracy and Precision of Blinded Independent Central Reviews (BICR) on Progression-Free Survival in Cancer Clinical Trials
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Author(s):
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Fenghai Duan*+ and Richard Walovitch and Vincent Girardi
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Companies:
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Brown University and WorldCare Clinical, LLC and WorldCare Clinical, LLC
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Keywords:
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accuracy ;
precision ;
blinded independent central reviews (BICR) ;
progression-free survival (PFS) ;
cancer ;
biostatistics
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Abstract:
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Background: A BICR is often recommended in open labeled trials and has the potential to also increase the accuracy and precision (A & P) of a subjective assessment. To understand its magnitude, a statistical model was developed to determine the effect on sample size and trial cost in progression-free survival (PSF) trials. Method: PFS times were simulated based on a tumor growth model using a median 180 days in the control arm; the treatment arm varied according to hazard ratios (HR) from 0.7-0.85. False positives were added for A and a log normal distribution of measurement error was used for P. Local evaluation (LE A=70% & P= 76%) were compared to different BICR paradigms with varying A &P measurement error A=70,90% & P=76, 80, 88%. Results: Compared to LE, all BICR paradigms decreased overall trial cost by $0.00037-2.7x107 and sample sizes by 12-435 with effect magnitude being greatest at higher HRs, A & P. Conclusion: Our study indicates that for trials with PFS based on a radiological assessment, BICR can be a cost effective strategy by decreasing sample sizes and trial costs.
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Authors who are presenting talks have a * after their name.
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