October 8, 2008 – SNM announced on Oct. 7, 2008, the creation of the Molecular Imaging Clinical Trials Network in response to the need for streamlined processes to utilize imaging biomarkers in clinical research and clinical practice.
A major barrier to the development of new and effective drugs is the time, complexity and cost of the regulatory process. There is widespread agreement that the use of imaging biomarkers in the drug development process can significantly reduce this burden and speed the timelines to clinical use. To specifically address this opportunity, SNM has designed a first-of-its-kind model for the use of imaging biomarkers in clinical trials that spans drug development, molecular imaging, radiolabeled probe development and manufacturing and regulatory issues to integrate the use of investigational imaging biomarkers into multicenter clinical trials.
The network is designed to provide centralized investigational new drugs (INDs) for biomarkers of interest to the pharmaceutical and imaging communities and to coordinate standardized imaging protocols across qualified multicenter clinical trial sites. The plan specifically includes creation of a Biomarker Use Pathway, which will provide SNM-sponsored centralized INDs that pharma can cross-reference for their multicenter trials. Large trials of investigational therapeutics can often demonstrate safety and efficacy more efficiently if imaging biomarkers are included in the protocols. SNM is taking the lead to establish FDA-friendly imaging biomarker protocols via approved INDs.
The network will also provide information on qualified radiopharmaceutical manufacturers to help design and develop clinical trials. SNM plans to work closely with FDA to assure proper definition of imaging and manufacturing protocols for biomarkers with central INDs approved through the network.
The network received approval for the first centralized IND in September of this year. The approved IND application is for F-18 fluorothymidine (FLT)—an investigational positron emission tomography (PET) imaging biomarker that has apparent promise for demonstration of tumor proliferation as a surrogate marker of effectiveness in the development of novel cancer therapies. Several pharmaceutical developers have already expressed interest in utilizing this approved IND in near-term clinical trial work. Active clinical trials utilizing FLT are expected to begin in 2009.
One challenge of imaging-based multicenter trials is ensuring that all entities follow a standardized protocol and that results are evaluated consistently. To help address this challenge, the new network has developed a PET phantom program that will help all registered sites in the Network to demonstrate current standard imaging capabilities, including state of technology, staff training and ability to adhere to standardized methods. Registry participation will require ongoing certification of qualifications.
In order to aid the imaging community in understanding the roles and responsibilities of participation in the registry, the phantom program and multicenter clinical trials, the Molecular Imaging Clinical Trials Network will sponsor ongoing forums to educate imagers. The first of these workshops is scheduled for Feb. 8–9, 2009, in Clearwater, FL. The workshop will provide detailed information on the clinical trials network, train attendees on the roles and responsibilities of participation in multicenter clinical trials and discuss the specific imaging and manufacturing protocols contained in the FLT IND.
SNM is actively building a registry now for imaging centers interested in participating in the first round of clinical trials.
For more information: www.snm.org/ClinicalTrials