The Role of fMRI in Drug Development: An Update.

Functional magnetic resonance imaging (fMRI) of the brain is a technology that holds great potential for increasing the efficiency of drug development for the central nervous system (CNS). In preclinical studies and both early- and late-phase human trials, fMRI has the potential to improve cross-species translation of drug effects, help to de-risk compounds early in development, and contribute to the portfolio of evidence for a compound's efficacy and mechanism of action. However, to date, the utilization of fMRI in the CNS drug development process has been limited. The purpose of this chapter is to explore this mismatch between potential and utilization. This chapter provides introductory material related to fMRI and drug development, describes what is required of fMRI measurements for them to be useful in a drug development setting, lists current capabilities of fMRI in this setting and challenges faced in its utilization, and ends with directions for future development of capabilities in this arena. This chapter is the 5-year update of material from a previously published workshop summary (Carmichael et al., Drug DiscovToday 23(2):333-348, 2018).