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Neutral Diagnosis: An Innovative Concept For Medical Device Clinical Trials, Bo Zhang, Shangyuan Ye, Sravya B. Shankara, Hui Zhang, Qingfeng Zheng Aug 2019

Neutral Diagnosis: An Innovative Concept For Medical Device Clinical Trials, Bo Zhang, Shangyuan Ye, Sravya B. Shankara, Hui Zhang, Qingfeng Zheng

Open Access Articles

Study design and statistical analysis are crucial in pivotal clinical trials to evaluate the effectiveness and safety of new medical devices under investigation. In recent years, innovative intraoperative in vivo breast tumor diagnostic devices have been proposed to improve the accuracy and surgical outcomes of breast tumor patients undergoing resection. Although such technologies are promising, investigators need to obtain statistical evidence for the effectiveness and safety of these devices by conducting valid clinical trials. However, the study design and statistical analysis for these clinical trials are complicated. While these trials are designed to provide real-time intraoperative diagnosis of cancerous tissue ...