Design of Prospective Clinical Trials for Assessment of PET.
This article will briefly review measures of accuracy for diagnostic tests. We will present valid, methodologically rigorous prospective clinical trial design features that avoid bias and that can generate high-quality evidence on the diagnostic accuracy of PET and its impact on diagnostic decision-making and therapeutic efficacy. Knowledge of the principles of Evidence-based Medicine, and an understanding of the key elements of designing a methodologically rigorous, prospective clinical trial will permit avoidance of the previous study design limitations and weaknesses of the existing literature on diagnostic imaging modalities. Published results of studies that are valid, obtained rapidly, and generalizable, will provide important support for the paradigm shift away from informal, opinion-driven decision-making in health care, toward a process that is evidence-based, rationale and considerate of our available resources and their most effective use in patient care.