Neutral diagnosis: An innovative concept for medical device clinical trials.

Neutral diagnosis: An innovative concept for medical device clinical trials. Contemp Clin Trials Commun. 2019 Dec;16:100436 Authors: Zhang B, Ye S, Shankara SB, Zhang H, Zheng Q Abstract 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, they also have clear therapeutic objectives to lower the reoperation rate of breast cancer surgery. This research article introduces the new concept of neutral diagnosis (ND), and the ND clinical trial design as an innovative study design to evaluate the effectiveness and safety of diagnostic devices with direct therapeutic purposes. A joint modeling approach is adopted to make inferences on the effectiveness and safety of these devices for non-neutral diagnosis (non-ND) clinical trials. Simulation studies were conducted to show the ef...
Source: Clinical Genitourinary Cancer - Category: Cancer & Oncology Authors: Tags: Contemp Clin Trials Commun Source Type: research