Practical Considerations for Adaptive Design Trial Execution
View Presentation *Weili He, Merck & Co., Inc Keywords: adaptive design, operational bias Clinical trials with adaptive features are more complex to implement than traditional designs such as fixed-sample or group sequential. Workarounds and/or inefficiencies in adaptive design (AD) trial implementations may result in human and material wastes or even in the introduction of operational biases that may potentially negate any gains we have in designing an AD trial and may even result in trial results that are not interpretable due to operational biases. In this presentation, we will present and share our experience in AD trial implementations in the areas of randomization considerations, IVRS vendor capability assessment and quality control, clinical supply strategy considerations, enrollment management and patient enrollment modeling and simulation, interim analysis planning, as well as blinding and unblinding management and the use of DMC.
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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