TABLE 6

Six Clinical Scenarios and Corresponding Main Challenges in Assessing Clinical Benefit When Current Standard Is Replaced with PET/CT

ScenarioMain challenge
A: Replacement of current invasive procedureEstablishment of noninferior accuracy
B: Improved accuracy of initial diagnosisEstimation of effect of delayed diagnosis
C: Improved accuracy of staging for curative treatment vs. palliative treatmentPET/CT provides no benefit for survival
D: Improved accuracy of staging for radiation vs. chemotherapyComparability of changers with all patients
E: Response evaluationEfficient second-line therapy implies imperfect gold standard
F: Rapid decisionLack of agreement on benefit of rapid decision