Evaluation of the Efficacy of Targeted Imaging Agents

Journal of Nuclear Medicine : Official Publication, Society of Nuclear Medicine
Michael M Graham, Wolfgang A Weber

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.

References

Apr 1, 1991·Medical Decision Making : an International Journal of the Society for Medical Decision Making·D G Fryback, J R Thornbury
Apr 3, 2007·Journal of Nuclear Medicine : Official Publication, Society of Nuclear Medicine·Michael GabrielIrene J Virgolini
Jul 17, 2009·Medical Decision Making : an International Journal of the Society for Medical Decision Making·Jeroen G LijmerPatrick M M Bossuyt
Aug 16, 2011·British Journal of Clinical Pharmacology·Paul M MatthewsRoger N Gunn
Dec 22, 2011·Journal of Nuclear Medicine : Official Publication, Society of Nuclear Medicine·Werner VachWolfgang A Weber
Feb 16, 2012·BMC Medical Research Methodology·Lukas P StaubLes Irwig
Jun 9, 2012·Journal of Nuclear Medicine : Official Publication, Society of Nuclear Medicine·Fülöp ScheiblerStefan Lange
Oct 5, 2012·Journal of Nuclear Medicine : Official Publication, Society of Nuclear Medicine·Rodney J HicksMichael S Hofman
Jun 12, 2013·Journal of Nuclear Medicine : Official Publication, Society of Nuclear Medicine·Alexander GorovetsLucie Yang
Aug 3, 2013·Journal of Nuclear Medicine : Official Publication, Society of Nuclear Medicine·Bruce J HillmanBrian C Abraham
Sep 13, 2013·Current Pharmaceutical Design·Evelien WynendaeleBart De Spiegeleer

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Citations

Apr 22, 2017·Diagnostics·Kasper F GuldbrandsenBarbara M Fischer
Sep 26, 2020·Cancers·Mark P S Dunphy, Nagavarakishore Pillarsetty
Aug 19, 2017·Journal of Nuclear Medicine : Official Publication, Society of Nuclear Medicine·Anthony F ShieldsLalitha K Shankar

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