Graham Michael M, Weber Wolfgang A
Department of Radiology, University of Iowa Hospitals and Clinics, Iowa City, Iowa; and
Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York.
J Nucl Med. 2016 Apr;57(4):653-9. doi: 10.2967/jnumed.115.169235. Epub 2016 Jan 14.
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.
本文介绍了我们对弗莱巴克（Fryback）和桑伯里（Thornbury）的分层方案的改编，该方案用于对诊断成像系统的效能进行建模。原方案旨在评估新的医学成像系统，但在应用于评估新的放射性药物时效果欠佳。所提出的改编方案专门针对评估靶向成像剂，有6个层级：体外特性表征、体内动物研究、初步人体研究、对临床护理的影响（管理变化）、对患者结局的影响以及社会效益。这些层级，尤其是前四个层级，隐含地定义了将一种制剂从放射化学合成实验室推向临床所需的研究顺序。完成第4层级（对临床护理的影响）应足以获得初步批准和报销。我们希望改编后的方案将有助于简化流程，并在未来几年协助新的靶向放射性药物获得批准。
