SNM, an international scientific and medical association based in Virginia, US that promotes the science, technology and practical applications of nuclear medicine, has launched the Molecular Imaging Clinical Trials Network to facilitate the integration of imaging biomarkers into clinical research.

The model spans drug development, molecular imaging and the development and manufacture of radiolabelled probes, as well as addressing regulatory issues around the use of imaging biomarkers in clinical trials. According to SNM, there is “widespread agreement” that applying imaging biomarkers to drug development can significantly reduce the time, complexity and cost of the regulatory process.

The network, which is expected to be fully functional in the first quarter of 2009, will develop centralised US investigational new drug (IND) applications for biomarkers of interest to the pharmaceutical and imaging sectors and will co-ordinate standardised imaging protocols across qualified multicentre trial sites. Pharmaceutical manufacturers will be able to cross-reference SNM-sponsored centralised INDs created through the association’s Biomarker Use Pathway for their multicentre studies.

The network’s first centralised IND – for F-18 fluorothymidine (FLT), an investigational positron emission tomography (PET) imaging biomarker with potential to demonstrate tumour proliferation as a surrogate marker of effectiveness in the development of novel cancer therapies – was approved in August. SNM says a number of drug developers have already expressed interest in using the approved IND, with active clinical trials incorporating FLT expected to begin next year.

The Molecular Imaging Clinical Trials Network will also provide information on qualified radiopharmaceutical manufacturers that can help to design and develop clinical trials. Moreover, SNM plans to work closely with the US Food and Drug Administration to ensure the proper definition of imaging and manufacturing protocols for biomarkers with centralised INDs approved through the network.

A key element of the network will be a registry of clinical imaging centres that will participate in ongoing assessment, monitoring and certification programmes to maintain imaging quality, standardisation and consistency. In the past, SNM notes, the FDA has struggled with inconsistent imaging methods at different centres, complicating the assessment of multicentre study results.

Another challenge has been making sure a standardised protocol is followed in imaging-based multicentre trials, and that the results are evaluated consistently. Accordingly, the new network has developed a PET phantom programme that will help all registered trial sites in the network to demonstrate current standard imaging capabilities. Participation in the registry of clinical imaging centres will require ongoing certification of qualifications, SNM pointed out.