TL3: High placebo response, what is your story?
*Anastasia Ivanova, UNC at Chapel Hill 

Keywords: placebo run-in, placebo lead-in, active run-in, SPCD

In a survey (Laughren, European Psychiatry, 2001) of placebo-control trials in depression and schizophrenia considered by FDA over 12 year period, 1987 through 1999, it was noted that many of the studies in which investigational drug could not be distinguished from placebo also included an active standard drug that could not be distinguish from placebo. Various designs have been proposed for trials with high placebo response including (1) placebo or active lead-in designs and (2) the sequential parallel comparison design (SPCD) where the trial is conducted in two stages with each stage being sufficiently long to observe the outcome. What is the best way to lower the impact of high placebo response on the success of a clinical trial?