Evaluation of novel drugs using fMRI in early-phase clinical trials: safety monitoring.
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.
George
Edward
E
Harvard Medical School, McLean Hospital, Belmont, MA 02478, USA. edgeorge@partners.org
Becerra
Lino
L
Upadhyay
Jaymin
J
Schmidt
Ulrich
U
Borsook
David
D
D002986:Clinical Trials as Topic / Q000379:methods*; D016903:Drug Monitoring / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions; D017408:Guidelines as Topic; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000009:adverse effects / Q000379:methods* / Q000592:standards; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*
D004364:Pharmaceutical Preparations