title: A procedural framework for good imaging practice in pharmacological fMRI studies applied to drug development #2: protocol optimization and best practices.
abstract: Functional magnetic resonance imaging (fMRI) experiments are more complex compared with standard radiological imaging, involving additional data streams and hardware along with complex analysis methods. Here, we propose guidelines based around mitigating risks associated with the complexities of the technique at the level of the individual imaging protocol, including workable and effective quality assurance/quality control procedures and rigorous, predefined, analysis pipelines. Our aim is to provide a framework for 'good imaging practice' (GIP), enabling these requirements to be addressed at an appropriate level of detail. The development of a procedural framework for GIP in pharmaceutical fMRI studies could lead to greater acceptance of the method within industry and facilitate validation and, eventually, qualification of the technique as an imaging biomarker.
authors.affiliation: Imaging Consortium for Drug Development, McLean Hospital, 115 Mill Street, Belmont, MA 02478, USA. a.schwarz@lilly.com
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: Alexander
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: D054316:Biomarkers, Pharmacological / Q000378:metabolism; 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
chemical_list: D054316:Biomarkers, Pharmacological