title: A procedural framework for good imaging practice in pharmacological fMRI studies applied to drug development #1: processes and requirements.
abstract: There is increasing interest in the application of quantitative magnetic resonance imaging (MRI) methods to drug development, but as yet little standardization or best practice guidelines for its use in this context. Pharmaceutical trials are subject to regulatory constraints and sponsor company processes, including site qualification and expectations around study oversight, blinding, quality assurance and quality control (QA/QC), analysis and reporting of results. In this article, we review the processes on the sponsor side and also the procedures involved in data acquisition at the imaging site. We then propose summary recommendations to help guide appropriate imaging site qualification, as part of a framework of 'good imaging practice' for functional (f)MRI studies applied to drug development.
authors.affiliation: Brain Imaging Center, McLean Hospital, 115 Mill St. Belmont, MA 02478, USA.
authors.forename: Adam J
authors.initials: AJ
authors.lastname: Schwarz
authors.forename: Lino
authors.initials: L
authors.lastname: Becerra
authors.forename: Jaymin
authors.initials: J
authors.lastname: Upadhyay
authors.forename: Julie
authors.initials: J
authors.lastname: Anderson
authors.forename: Richard
authors.initials: R
authors.lastname: Baumgartner
authors.forename: Alexandre
authors.initials: A
authors.lastname: Coimbra
authors.forename: Jeff
authors.initials: J
authors.lastname: Evelhoch
authors.forename: Richard
authors.initials: R
authors.lastname: Hargreaves
authors.forename: Brigitte
authors.initials: B
authors.lastname: Robertson
authors.forename: Smriti
authors.initials: S
authors.lastname: Iyengar
authors.forename: Johannes
authors.initials: J
authors.lastname: Tauscher
authors.forename: David
authors.initials: D
authors.lastname: Bleakman
authors.forename: David
authors.initials: D
authors.lastname: Borsook
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D015195:Drug Design; D004345:Drug Industry / Q000379:methods; D017408:Guidelines as Topic; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000379:methods* / Q000592:standards; D011786:Quality Control