alexa A Simulation Study to Evaluate Accuracy and Precision of Blinded Independent Central Reviews of Progression-free Survival in Cancer Clinical Trials
ISSN: 2167-0870

Journal of Clinical Trials
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Review Article

A Simulation Study to Evaluate Accuracy and Precision of Blinded Independent Central Reviews of Progression-free Survival in Cancer Clinical Trials

Walovitch R1*, Girardi V1 and Duan F2
1WorldCare Clinical, LLC, 7 Bulfinch Place, Boston, MA 02114, USA
2Department of Biostatistics and Center for Statistical Sciences, Brown University, Providence, RI, USA
Corresponding Author : Walovitch R
WorldCare Clinical, LLC
7 Bulfinch Place
Boston, MA 02114, USA
Tel: +1 617 583 1606
Fax: +1 513 352 9564
E-mail: [email protected]
Received July 25, 2013; Accepted September 20, 2013; Published September 23, 2013
Citation: Walovitch R, Girardi V, Duan F (2013) A Simulation Study to Evaluate Accuracy and Precision of Blinded Independent Central Reviews of Progressionfree Survival in Cancer Clinical Trials. J Clin Trials 3:142. doi:10.4172/2167-0870.1000142
Copyright: © 2013 Walovitch R, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

Purpose: To model the effect of accuracy and precision on hazard ratios, sample size and overall trial cost in Progression-Free Survival (PFS) trials using different Blinded Independent Review (BICR) paradigms.
Method: PFS times were simulated based on a tumor growth model using a median 180 days in the treatment arm; the control arm varied according to Hazard Ratios (HR) from 0.7-0.85. False positives were added for varying accuracy (1-False positive rate) and a log normal distribution of measurement error was used for varying precision. Local Evaluation (LE) accuracy of 70% and measurement error’s standard deviation of 0.30 were compared to different BICR paradigms with varying accuracy and precision (i.e., accuracy =70,90% & precision .30,.25,.20).
Results: Compared to LE, all BICR paradigms decreased overall trial costs by $ 0.0037 - 26.6.3×106 and sample sizes by 12-435 with effect magnitude being greatest at higher HRs, higher accuracy and lower measurement error.
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. More importantly, the study provides a quantitative indication of how changing accuracy and precision can alter sample size projections and trial cost.

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