  Clinical trials are considered as the golden standard for medical device
validation. However, many sacrifices have to be made during the design and
conduction of the trials due to cost considerations and partial information,
which may compromise the significance of the trial results. In this paper, we
proposed a model-based pre-clinical trial framework using statistical model
checking. Physiological models represent disease mechanism, which enable
automated adjudication of simulation results. Sampling of the patient
parameters and hypothesis testing are performed by statistical model checker.
The framework enables a broader range of hypothesis to be tested with
guaranteed statistical significance, which are useful complements to the
clinical trials. We demonstrated our framework with a pre-clinical trial on
implantable cardioverter defibrillators.
