Incorporating Functional MRI into Clinical Pharmacology Trials
Functional magnetic resonance imaging (fMRI) offers great hope as a broadly applicable tool for identifying CNS drugs effects and informing key triage decisions during drug development. However, given the levels of investment at stake, pharmacological fMRI still faces high confidence and logistical hurdles before it is routinely used by the pharmaceutical industry to inform Go–No Go decisions. While there are many ongoing efforts to bridge these gaps through novel fMRI paradigm designs and analytical approaches, there has been less discourse on the practical aspects of implementing fMRI into early clinical drug development settings. Most pharmaceutical companies do not have their own internal capability for conducting fMRI clinical pharmacology studies, and most industry clinical monitors and field monitors charged with study oversight are not intimately familiar with fMRI approaches. This can make study coordination and monitoring a confusing and daunting task. This chapter provides clinical pharmacology professionals with some considerations and suggestions for optimizing the success of fMRI experiments conducted in the early phases of drug development.
KeywordsCerebral Blood Flow Blood Oxygenation Level Dependent Arterial Spin Label Blood Oxygenation Level Dependent Signal Blood Oxygenation Level Dependent Response
We are grateful for the thoughtful suggestions provided by Michael Klimas and David Hewitt of Merck & Co., Inc.
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