Existing measures designed to test the efficacy of drugs rely primarily on paper-and-pencil tests. These outcome measures alone have been shown to lack the reliability and sensitivity required to quickly push potential therapies through the clinical development process.

The FDA states “Applied scientific work has not done enough to create new tools that get fundamentally better answers about the safety and effectiveness of new products; in faster time frames, with more certainty, and at lower costs.”

Functional Magnetic Resonance Imaging (fMRI) has enormous potential to assist in the drug development process. fMRI is an extremely sensitive testing tool that provides increased reliability and reproducibility to meet the FDA’s challenge.

How can Neurognostics Help?

Neurognostics specializes in utilizing fMRI for the diagnosis and assessment of central nervous system (CNS) disorders. By providing complete clinical trial support services, our team can assist with everything from trial design assistance and fMRI scanning to the complete analysis of your results. Using our fMRI system significantly reduces the number of subjects required for clinical trials, minimizes a drug’s time to market, and ultimately provides substantial development savings for new CNS therapeutics.

Trial Design Assistance

• Selection of biomarkers & cognitive tasks
• Analysis of sample size requirements

• Development of trial protocol
• Selection of testing sites

fMRI Scanning

• Coordination of multiple trial sites
• Outfitting of fMRI hardware and software
• Oversight of fMRI scans

Analysis of Results

• Correlation of fMRI results with existing outcome measures
• Comparison with normative population
• Formalized results and reporting

The Role of fMRI in Drug Discovery, PDF, 2006