The Clinical Trials Network of the Society of Nuclear Medicine
Section snippets
New Radiopharmaceuticals
There have been remarkably few new radiopharmaceuticals approved. The reason for this is multifactorial: (1) The projected market for new diagnostic and therapeutic radiopharmaceuticals is relatively small, especially compared with most therapeutic pharmaceuticals. Therefore, the return on investment is not as high. (2) Investigational new drug (IND) applications for radiopharmaceuticals are subject to the same regulatory requirements as for new drugs, which means they come under the same level
Assessment of Response to Therapy
The use of novel imaging techniques can potentially provide sponsors of therapeutic trials an early measure of response, or lack of response, in phase 1 or phase 2 testing. The “go or no-go” decision to develop a new molecular entity for therapy is critically important for pharmaceutical companies because investment in later phase trials can cost millions of dollars to learn that a new therapy does not perform effectively. Making the decision to terminate development of a new drug early is as
Challenges With Molecular Imaging Trials
The pharmaceutical industry's initial experience in trials incorporating PET imaging has not been uniformly successful. The imaging part of the trials can be complex, needs to be scheduled in a consistent relationship to the therapy schedule, and needs to be performed in a consistent and standardized manner with adherence to the clinical trial protocol. Many of the companies and the associated Clinical Research Organizations (CROs) are not familiar with the requirements of PET imaging and the
Accomplishments
Some key accomplishments that have been achieved by the end of the first year of operations are the following:
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3 pharmaceutical partners have now joined with the CTN and have agreed to provide financial support of the required infrastructure and processes;
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The CTN imaging site registry database is functional, and currently includes more than 240 sites worldwide who have expressed interest (more than 25% participation from outside the United States);
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the manufacturer's registry has been initiated,
Plans
Our goal is to have at least 40 US and 20 non-US sites scanner validated and fully qualified by the end of 2010. The top 3 initiatives that are critical to successful implementation of the CTN, and are the short-term goals for 2010 are:
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A broad overview of positron emission tomography radiopharmaceuticals and clinical applications: What is new?
2011, Seminars in Nuclear MedicineCitation Excerpt :As shown in Table 4, several companies are conducting phase I, II, and III trials with several nonproprietary PET drugs. The Clinical Trials Network (CTN) of the Society of Nuclear Medicine (SNM) was formed in 2008 to address the challenges and opportunities that exist in developing protocols, manufacturing the necessary investigational molecular imaging agents (the nonproprietary agents), and collaborating with pharmaceutical manufacturers to assure high-quality imaging at multiple research centers.34 In addition, an important goal of the SNM-CTN is to establish relationships with pharmaceutical manufacturers who are developing clinical trials for their drug products and, who would be interested in using the generic agents to acquire the necessary safety and efficacy data required for eventual approval of these agents.
The evolution of imaging in cancer: Current state and future challenges
2011, Seminars in OncologyCitation Excerpt :SNM CTN sought to provide a centralized IND process, allowing industries to cross-reference the centralized IND for large multicenter trials. Establishment of standardized imaging guidelines for other radiotracers and molecular imaging agents remains a formidable hurdle despite the SNM CTN effort.120 Because molecular imaging has been performed extensively in the service of cancer research, new discoveries in and applications of molecular imaging research have been developing in parallel with discoveries emanating from the cell biology laboratory.
Letter from the Editors: Clinical trials in nuclear medicine
2010, Seminars in Nuclear MedicineDiagnostic reference levels of CT radiation dose in whole-body PET/CT
2016, Journal of Nuclear Medicine<sup>99m</sup>Tc-Annexin A5 quantification of apoptotic tumor response: a systematic review and meta-analysis of clinical imaging trials
2015, European Journal of Nuclear Medicine and Molecular Imaging