What Is The Definition And Construction Principle Of The Target Value In The Design Of Single-group Target Value Clinical Trials?

The target value is the recognized minimum criteria of the effectiveness/safety evaluation indexes for certain types of medical devices, including objective performance criteria (OPC) and performance goal (PG). The target value is usually a two-category (such as valid/invalid) indicator or a quantitative indicator, including the target value and the one-sided confidence interval limit (usually 97.5%). In a single-group clinical trial, the effectiveness/safety of the device in question is evaluated by examining whether the results of the main evaluation indicators are within the range of target value. Thus, a clinically meaningful target values needs to specify in advance. Because there is no control group, a single-group target value design clinical trial cannot confirm the superiority, equivalent, or non-inferiority of the device in question. It can only confirm that the effectiveness/safety of the device in question meets the recognized minimum criteria.
The construction of target values usually requires comprehensive collection of clinical research data with a certain level of quality and a considerable number of cases, and scientific analysis (such as Meta analysis). With the improvement of device technology and clinical skills, OPC may change, and clinical data needs to be re-analyzed to confirm.
When considering statistical analysis, the point estimates and the one-sided confidence interval limits for the primary evaluation indicators need to be calculated and compared with the target values.