title: Evaluation of diagnostic imaging technologies and therapeutics devices: better information for better decisions: proceedings of a multidisciplinary workshop.
abstract: We are entering an era in which the success of biomedical science and the increasing understanding of the value of evidence for practice are in a state of tension. This tension is especially notable in the device arena, in which the short life cycles and iterative nature of development are at odds with current design constructs of the types of clinical trials that provide evidence for medical decision making. The financial pressure arising from strained budgets and expanding costs from the aging of the population and the continued development of new technology heightens the need for a focus on new approaches. Given this background, a group of experts representing constituencies with different perspectives were convened for a day and a half to discuss key issues and their potential solutions. Because of the complex and heterogeneous nature of the environments in which devices are used, the meeting focused on 3 broad, general uses of devices: imaging, risk stratification, and therapeutics. The goal of the meeting was to develop a preliminary list of ideas that could be framed as researchable questions or constructs for consideration by policy makers that ultimately might lead to improvements in the current system. Across diagnostic imaging, risk stratification devices, and therapeutic devices, the crosscutting issues can be identified: We need better methods of collaborative funding and priority setting, improved and more flexible methods, and new approaches to the integration of federal agencies in overseeing the system.
authors.affiliation: Duke Clinical Research Institute, Durham, NC 27715, USA. calif001@mc.duke.edu
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
mesh_terms: D000544:Alzheimer Disease / Q000175:diagnosis; D020811:Biomedical Technology / Q000191:economics / Q000458:organization & administration*; D014487:Centers for Medicare and Medicaid Services, U.S.; D003299:Cooperative Behavior; D016757:Death, Sudden, Cardiac / Q000453:epidemiology; D003657:Decision Making; D017147:Defibrillators, Implantable; D018795:Device Approval; D003952:Diagnostic Imaging / Q000191:economics / Q000295:instrumentation* / Q000379:methods; D004869:Equipment Safety; D006302:Health Services Research; D006801:Humans; D007373:Interinstitutional Relations; D008297:Male; D011470:Prostatic Hyperplasia / Q000628:therapy; D016032:Randomized Controlled Trials as Topic; D013673:Technology Assessment, Biomedical; D020728:Transurethral Resection of Prostate; D014481:United States; D014486:United States Food and Drug Administration; D018487:Ventricular Dysfunction, Left / Q000175:diagnosis / Q000628:therapy; D000078329:Workforce