title: Evaluation of the Efficacy of Targeted Imaging Agents.
abstract: This paper presents our adaptation of Fryback and Thornbury's hierarchical scheme for modeling the efficacy of diagnostic imaging systems. The original scheme was designed to evaluate new medical imaging systems but is less successful when applied to evaluate new radiopharmaceuticals. The proposed adaptation, which is specifically directed toward evaluating targeted imaging agents, has 6 levels: in vitro characterization, in vivo animal studies, initial human studies, impact on clinical care (change in management), impact on patient outcome, and societal efficacy. These levels, particularly the first four, implicitly define the sequence of studies needed to move an agent from the radiochemistry synthesis laboratory to the clinic. Completion of level 4 (impact on clinical care) should be sufficient for initial approval and reimbursement. We hope that the adapted scheme will help streamline the process and assist in bringing new targeted radiopharmaceuticals to approval over the next few years.
authors.affiliation: Department of Radiology, University of Iowa Hospitals and Clinics, Iowa City, Iowa; and michael-graham@uiowa.edu.
authors.forename: Michael M
authors.initials: MM
authors.lastname: Graham
authors.affiliation: Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York.
authors.forename: Wolfgang A
authors.initials: WA
authors.lastname: Weber
mesh_terms: D000818:Animals; D017277:Drug Approval; D016503:Drug Delivery Systems / Q000379:methods*; D006801:Humans; D049268:Positron-Emission Tomography / Q000379:methods* / Q000592:standards*; D019275:Radiopharmaceuticals / Q000493:pharmacokinetics / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D019275:Radiopharmaceuticals
keywords: FDA approval process; efficacy; evaluation; radiopharmaceutical