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Review
. 2010 Aug;15(15-16):684-9.
doi: 10.1016/j.drudis.2010.05.008. Epub 2010 May 27.

Evaluation of novel drugs using fMRI in early-phase clinical trials: safety monitoring

Edward George  1 , Lino Becerra, Jaymin Upadhyay, Ulrich Schmidt, David Borsook
Affiliations
Review

Evaluation of novel drugs using fMRI in early-phase clinical trials: safety monitoring

Edward George et al. Drug Discov Today. 2010 Aug.

Abstract

A advances in functional magnetic resonance imaging (fMRI) permit the possibility of helping with dose ranging, as well as potential drug efficacy and side-effect profiles. However there are no current guidelines or standards for fMRI that meet established standards of care. Guidelines must be adopted to be used when patients are exposed to novel drugs, in particular, when immediate access to the patient is limited. When used in initial, MRI mandates certain safety standards because subjects are positioned in the magnet thereby limiting direct observation, communication or immediate access in an emergency; in testing new drugs using fMRI, we suggest that safety guidelines merit discussion and definition. This could lead to the adoption of standards. Some of these issues are unique to the application of the technology in early-phase trials.

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Conflict of interest statement

Conflict of Interest: None of the authors have any conflicts to declare.

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