PLACEBO RESPONSE REDUCTION If you are running a pain trial involving an analgesic medication and want to minimize “noise” from your trial, the Placebo Response Reduction Program can help. WHAT: Set of training materials for subjects and staff on neutral expectation and establishing the research alliance. WHY: Helps improve assay sensitivity. Intentional “neutralization” of patient expectations can reduce the placebo response. HOW: Integrates seamlessly into the design of your clinical trial. Staff training is conducted at the Investigator meeting, and staff materials allow for automatic refresher training prior to each subject training. Subject brochure can be reviewed during each study visit. The Placebo Response Reduction Program was developed in trials across various indications with many trials conducted in: Placebo responses result in failed trials (illustration): • Migraine • Interstitial Cystitis • Painful Diabetic Neuropathy • Painful Lumbar Radiculopathy ...and has been implemented in a large-scale clinical trial of a Phase III Program on Knee Osteoarthritis involving: 25 Sites 600 Subjects Large responses to placebo reduce differences between drug and placebo, leading to trial failure 232 Pond Street, Natick, MA 01760 (781) 444-9605 info@analgesicsolutions.com Good pain reports from patients lead to a smaller SD, making the response to active drug statistically significantly different from placebo (* = p < 0.05) (even though patients in placebo group had a response) analgesicsolutions.com