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.

翻译：临床试验被视为医疗装置鉴定的黄金标准,但是,在设计和进行试验期间,由于成本考虑和部分信息,必须作出许多牺牲,这可能损害试验结果的重要性。在本文件中,我们提议采用统计模型检查,建立一个以示范为基础的临床前试验框架。生理模型代表疾病机制,能够自动判断模拟结果。病人参数和假设测试由统计模型检查员进行取样。这个框架使更广泛的假设在设计和进行试验时具有一定的统计意义,这是对临床试验的有益补充。我们展示了我们的框架,对植入式硬盘除颤器进行了临床前试验。