Reducing clinical trial costs by detecting and measuring the placebo effect and treatment effect using brain imaging

Stud Health Technol Inform. 2013:184:6-12.

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.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Brain / drug effects*
  • Clinical Trials as Topic / economics*
  • Clinical Trials as Topic / methods
  • Cost Savings / economics
  • Cost Savings / methods
  • Humans
  • Image Interpretation, Computer-Assisted / methods
  • Neuroimaging / economics*
  • Neuroimaging / methods*
  • Outcome Assessment, Health Care / economics*
  • Outcome Assessment, Health Care / methods
  • Pharmaceutical Preparations / administration & dosage
  • Pharmaceutical Preparations / economics*
  • Placebo Effect*
  • United States

Substances

  • Pharmaceutical Preparations