Research on biological markers of disease process and treatment response were highlighted at the 48th annual New Clinical Drug Evaluation Unit meeting, “New Research Approaches for Mental Health Interventions,” convened by the NIMH, May 27-30 in Phoenix.
In a workshop on biomarkers, pharmacogenetics, and pharmacogenomics, Michael Henry, MD, of Caritas St Elizabeth’s Medical Center in Boston, indicated that technological improvements in scanner design, along with increasing understanding of neuropathophysiology, “offer an unprecedented opportunity for utilizing brain imaging techniques to improve the precision of clinical trials.”
Henry foresees the application of technologies such as MRI, PET, and single photon emission CT to reduce diagnostic variability in study populations, measure drug penetration of target sites, and establish biomarkers of therapeutic efficacy. Although imaging in clinical trials is most common in cardiology and oncology, Henry noted its recent use in trials of agents for dementia, depression, and psychosis.
Andrew Leon, PhD, of Weill Medical College of Cornell University, New York, agreed with the described potential of biomarkers to serve as primary end points in clinical trials but reminded conferees that the current status is either as secondary end points or “hypothesized moderators of outcome.” To go forward, he asserted, clinical trials will need to include validity testing of putative biomarkers.
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