title: The Clinical Trials Network of the Society of Nuclear Medicine.
abstract: The Clinical Trials Network of the Society of Nuclear Medicine was formed to provide quality assurance of both imaging and radiopharmaceutical manufacturing in clinical trials. The intention is to register and qualify a large number (>200) of sites, both in the United States and internationally, to be able to do the positron emission tomography imaging part of clinical trials. Initially, the types of trials to be supported include evaluation of novel radiopharmaceuticals and trials that use approved or experimental radiopharmaceuticals for early assessment of tumor response to novel chemotherapy agents. The Clinical Trials Network is organized into 7 committees that provide overall oversight and strategic guidance, database management, site qualification and monitoring, scanner validation, clinical site orientation, technologist education, trial design, and a manufacturer's registry. At the end of the first year, more than 200 potential clinical trial sites and more than 125 manufacturing sites have expressed interest in participating. The qualification process is well underway. Funding is being provided by 3 large pharmaceutical companies. An investigational new drug application has been obtained for F-18 fluorothymidine that is held by Society of Nuclear Medicine to allow simplification of data management during multisite trials with F-18 fluorothymidine. A second investigational new drug application is in preparation for F-18 fluoromisonidazole. A supply of oncology chest phantoms has been manufactured and have been shipped to numerous sites for scanner validation. Educational materials are being developed for the physicians, technologists, and research coordinators at the sites. This is an important initiative that is likely to help significantly expand the role of molecular imaging and will help bring the right treatment to the right patient at the right time.
authors.affiliation: Department of Radiology, University of Iowa, Iowa City, IA 52242, USA. michael-graham@uiowa.edu
authors.forename: Michael M
authors.initials: MM
authors.lastname: Graham
mesh_terms: D002986:Clinical Trials as Topic; D017277:Drug Approval; D006801:Humans; D057054:Molecular Imaging; D009683:Nuclear Medicine / Q000193:education / Q000458:organization & administration* / Q000592:standards; D011786:Quality Control; D019275:Radiopharmaceuticals / Q000627:therapeutic use; D012958:Societies, Scientific / Q000458:organization & administration* / Q000592:standards; D016896:Treatment Outcome
chemical_list: D019275:Radiopharmaceuticals