title: Using CQI to prevent the placebo effect from causing failed clinical trials.
abstract: One of the greatest obstacles to bringing drugs to market is one of the most complex--the human mind. Despite the billions invested in R&D, a fundamental issue in drug development is that most patients' responses are enhanced or affected by the "placebo effect." An ongoing methodology for reducing the impact of placebo effect should be built into the clinical study design at the outset based on a continuous quality improvement model. A CQI program that requires continuous evaluation of study participant data and rater training is a way to improve study performance and, therefore, ensure more valid studies and reliable outcomes.
authors.affiliation: Department of Psychiatry, Rush-Presbyterian-St. Luke's Medical Center, Chicago, IL, USA.
authors.forename: J
authors.initials: J
authors.lastname: Fawcett
authors.forename: M E
authors.initials: ME
authors.lastname: Sinioris
mesh_terms: D018849:Controlled Clinical Trials as Topic / Q000592:standards*; D005069:Evaluation Studies as Topic; D006801:Humans; D018579:Patient Selection; D015990:Placebo Effect; D017749:Total Quality Management; D016896:Treatment Outcome; D014481:United States