Addressing the High Placebo Response in Neuroscience Clinical Trials: Doubly-Randomized Delayed Start Design to Increase Efficiency and Likelihood of Success
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*Pilar Lim, Janssen R&D  Qing Liu, Janssen Research & Development  Jaskaran Singh, Janssen Research and Development, LLC  David Lewin, Janssen Research and Development, LLC  Barry Schwab, Janssen Research and Development, LLC  Justine Kent, Janssen Research and Development, LLC 

Keywords: placebo response, enrichment, adaptation

High placebo response rates have been a major source of difficulty in many neuroscience clinical trials and their effects have been difficult to overcome in developing new compounds. This difficulty has led to high failure rates in mood disorder trials, among others, even in trials with known effective drugs. To address this issue, this talk will offer insights into new enrichment design strategies, as well as approaches to reducing investigator and subject expectation bias. The concepts of enrichment, bias, and adaptation in clinical trials will be discussed. A newly proposed design will be introduced and its benefits examined relative to existing approaches in the literature.