SNM Creates Molecular Imaging Clinical Trials Network to Streamline Regulatory Processes

EurekAlert! reports that SNM has announced the creation of the Molecular Imaging Clinical Trials Network, which is a model for the use of imaging biomarkers in clinical trials in order to reduce the burden of the time, complexity, and cost of the regulatory process.

This network is designed to provide centralized investigational drugs for biomarkers of interest to pharmaceutical and imaging communities, and then coordinate certain imaging protocols across many clinical trial sites. SNM President Robert W. Atcher mentions:

"The plan specifically includes creation of a Biomarker Use Pathway, which will provide SNM-sponsored centralized INDs that pharmaceutical manufacturers 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."

It will be interesting to see how effective this network will be in streamlining the regulatory process once it becomes fully functional in the first quarter of 2009.