Robustness Evaluation of Computer-aided Clinical Trials for Medical Devices

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Real-Time and Embedded Systems Lab (mLAB)
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CPS Medical
Computer-aided
Clinical trials
Bayesian sensitivity analysis
Robustness
Medical devices
Implantable cardiac devices
Computer Engineering
Electrical and Computer Engineering
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Abstract

Medical cyber-physical systems, such as the implantable cardioverter defibrillator (ICD), require evaluation of safety and efficacy in the context of a patient population in a clinical trial. Advances in computer modeling and simulation allow for generation of a simulated cohort or virtual cohort which mimics a patient population and can be used as a source of prior information. A major obstacle to acceptance of simulation results as a source of prior information is the lack of a framework for explicitly modeling sources of uncertainty in simulation results and quantifying the effect on trial outcomes. In this work, we formulate the Computer-Aided Clinical Trial (CACT) within a Bayesian statistical framework allowing explicit modeling of assumptions and utilization of simulation results at all stages of a clinical trial. To quantify the robustness of the CACT outcome with respect to a simulation assumption, we define δ-robustness as the minimum perturbation of the base prior distribution resulting in a change of the CACT outcome and provide a method to estimate the δ-robustness. We demonstrate the utility of the framework and how the results of δ-robustness evaluation can be utilized at various stages of a clinical trial through an application to the Rhythm ID Goes Head-to-head Trial (RIGHT), which was a comparative evaluation of the safety and efficacy of specific software algorithms across different implantable cardiac devices. Finally, we introduce a hardware interface that allows for direct interaction with the physical device in order to validate and confirm the results of a CACT for implantable cardiac devices.

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2019-03-14
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Real-Time and Embedded Systems Lab (mLAB)
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2023-05-17T21:50:14.000
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@article{jang_iccps2019, Address = {Montreal, QC, Canada}, Author = {Kuk Jin Jang and Yash Vardhan Pant and Bo Zhang and James Weimer and Rahul Mangharam}, Doi = {10.1145/3302509.3311058}, Keywords = {Computer-aided, Clinical trials, Bayesian sensitivity analysis, Robustness, Medical devices, Implantable cardiac devices}, Month = {April 16-18}, Organization = {ACM}, Publisher = {10th ACM/IEEE International Conference on CyberPhysical Systems (with CPS-IoT Week 2019) (ICCPS '19)}, Title = {Robustness Evaluation of Computer-aided Clinical Trials for Medical Devices}, Year = {2019}}
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