Despite general agreement that molecular imaging facilitates drug development, it has been historically difficult for the pharmaceutical community to effectively use molecular imaging agents in their multicenter clinical trials. This is due to a number of factors including lack of standardized clinical protocols for molecular imaging agents, lack of trained and certified imaging sites and lack of centralized, easy to cross-reference INDs for molecular imaging agents. One of the goals of the SNMMI Clinical Trials Network (CTN) is to facilitate community access to investigational molecular imaging radiopharmaceuticals. To accomplish this, the following strategies have been identified:
F-18 FLT is one example of an under-utilized radiopharmaceutical. At the Institute of Medicine (IOM) meeting in Washington, DC, on October 7, 2007, drugs and biologics developers of investigational therapeutics (Pfizer, Amgen, and Genentech) met with Dr. Janet Woodcock of the FDA and representatives from the National Cancer Institute. The developers explained that F-18 FLT, an investigational PET imaging radiopharmaceutical, has apparent promise as an imaging biomarker for demonstration of tumor proliferation.
The review process subsequently resulted in the SNMMI/CTN receiving approval for the first centralized IND for F-18 FLT on October 1, 2008. This IND is fully-documented and addresses - and resolves - current barriers for cross-reference implementation in multicenter studies, incorporating:
Please see FAQs for additional information on Centralized Radiopharmaceutical INDs.