The role of the core imaging laboratory in multicenter trials.
The incorporation of imaging biomarkers and clinical trials is now common. Because of the multiple technical, clinical, and regulatory demands to ensure high-quality quantitative information, the core laboratory serves as a critical intermediary between the study sponsor and the site. It provides unique expertise not found in typical clinical research organizations. This expertise goes far beyond the passive receipt of images for conductance of central reads of data and includes the proactive and early involvement in the selection of sites for imaging, the qualification and assistance for managing the local site logistics, on-the-fly and active quality control of imaging data in close working relationship with sites, and preparation for and conductance of central image reads or quantification in a manner which bears up to regulatory scrutiny.
Seibyl
John
J
Molecular Neuroimaging, LLC, Institute for Neurodegenerative Disorders, and Yale University School of Medicine, New Haven, CT, USA. jseibyl@indd.org
Marek
Kenneth
K
Zubal
I George
IG
D006801:Humans; D007753:Laboratories / Q000458:organization & administration; D057054:Molecular Imaging / Q000592:standards; D015337:Multicenter Studies as Topic / Q000379:methods* / Q000592:standards; D011786:Quality Control