What Are The Principles For Selecting Devices For Control Group In Parallel Controlled Clinical Trials?

For the therapeutic products, when selecting the positive control, it is preferred to choose approved similar devices that have clinically recognized efficacy and safety. If there are reasonable grounds that cannot select an approved similar device, then firstly, an approved device which is as similar to the device in question as possible can be chose as a positive control. Secondly, the standard treatment methods can be considered, which include multiple situations, such as medications. When the test device does not have the same or similar marketed products or corresponding standard treatment methods, the trial design needs to consider the comfort control if there is a comfort effect in the efficacy of the test device. At this time, ethical factors need to be considered comprehensively. If the efficacy of the marketed product has not been clinically recognized, the trial design can consider standard treatment methods or comfort control according to the specific situation, and the administrative counterparts should fully justify the selection of the control.