title: Reducing clinical trial costs by detecting and measuring the placebo effect and treatment effect using brain imaging.
abstract: Although the placebo effect is known to have a strong impact on the outcomes of clinical trials, methods for measuring it are limited to physiological observations. We propose a method of localizing, identifying and measuring placebo and treatment-induced networks in the brain using functional neuroimaging. Measuring the relative activation of these "placebo" brain networks serves as a proxy for the placebo effect contained within the variable of interest (depression rating, blood pressure, etc). Analogous to the difference between a paired and unpaired t-test, this allows for a sharp gain in power and reduction in the sample sizes needed in clinical trials, potentially leading to a drastically smaller sample sizes for establishing efficacy, a shorter time-to-market for a drug, and a drastic reduction in the cost of bringing new drugs into the market.
authors: Laboratory of Integrative NeuroImaging Technology, Los Angeles, CA 90095-1406, USA. ariana82@ucla.edu
authors: Ariana
authors: A
authors: Anderson
authors: Mark S
authors: MS
authors: Cohen
mesh_terms: D001921:Brain / Q000187:drug effects*; D002986:Clinical Trials as Topic / Q000191:economics* / Q000379:methods; D017046:Cost Savings / Q000191:economics / Q000379:methods; D006801:Humans; D007090:Image Interpretation, Computer-Assisted / Q000379:methods; D059906:Neuroimaging / Q000191:economics* / Q000379:methods*; D017063:Outcome Assessment, Health Care / Q000191:economics* / Q000379:methods; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000191:economics*; D015990:Placebo Effect; D014481:United States
chemical_list: D004364:Pharmaceutical Preparations
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