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Activity Number: 536 - Contributed Poster Presentations: Section on Statistics in Imaging
Type: Contributed
Date/Time: Wednesday, August 1, 2018 : 10:30 AM to 12:20 PM
Sponsor: Section on Statistics in Imaging
Abstract #333139
Title: Adaptive designs in multi-reader multi-case clinical trials of imaging devices
Author(s): Weijie Chen* and Zhipeng Huang and Lucas Tcheuko and Frank Samuelson
Companies: FDA/CDRH and FDA/CDRH and FDA/CTP and FDA/CDRH
Keywords:
Abstract:

Multi-reader multi-case (MRMC) studies are often used for the evaluation of medical imaging devices. In MRMC studies, both readers and cases are treated as random samples and contribute to the uncertainty of the estimated diagnostic performance - area under the ROC curve or AUC. Due to limited prior information, the sizing of such studies is often inaccurate and it is desired to adaptively resize the study towards a target power after an interim analysis. Methodologies have not been established for adaptive MRMC studies. The challenge lies in the fact that sizing involves both readers and cases and there is a complex correlation structure in MRMC data. We fill this gap by developing adaptive MRMC design methodologies that allow resizing the study after an interim analysis while adjusting the critical value for hypothesis testing to control the type I error from inflation. Analytical results have been derived for both split-plot designs and fully-crossed designs. Our simulations show that the adaptive resizing can boost the power towards the target power while controlling the type I error under a variety of simulation conditions.


Authors who are presenting talks have a * after their name.

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