Addressing the High Placebo Response in Neuroscience Clinical Trials: Doubly-Randomized Delayed Start Design to Increase Efficiency and Likelihood of Success
View Presentation *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.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC