All Times EDT
Keywords: diagnostic device, adjunctive use, clinical validation, clinical outcome
For diagnostic devices, the pivotal clinical evaluation is usually conducted in a clinical performance/validation study for accuracy/agreement. However, with an increasing number of innovative diagnostic tests as aid in clinical practice, a clinical performance study may also evaluate clinical outcomes such that these outcomes are the primary focus of the study per proposed indication for use (IFU) in addition to the traditional evaluation of accuracy/agreement. In such diagnostic device studies (e.g. software devices for adjunctive use), subjects are assigned to two arms (i.e. control arm with SOC/predicate device and intervention arm with adjunctive use of the test device). The clinical outcome parameters (or surrogates) are then assessed at planned intervals to determine the effectiveness (and/or safety) of the intervention with the adjunctive use of the test device. This roundtable will discuss the scenarios and issues when the clinical outcome studies are needed for diagnostic devices.