Phase I/II Adaptive Design in Early Phase Clinical Development
View Presentation *Shein-Chung Chow, Duke University, School of Medicine Keywords: Seamless adaptive design; Two-stage adaptive design Depending upon the adaptations considered, Chow and Chang (2006) classifies adaptive designs into several types of adaptive designs. Among these adaptive designs, seamless adaptive designs (e.g., phase I/II or phase II/III adaptive design) are probably the most commonly employed in pharmaceutical/clinical development. In early clinical development, phase I/II adaptive designs are two-stage adaptive designs that combine a phase I study (Stage 1) and a phase II trial (Stage 2) into a single trial. In practice, phase I/II adaptive designs can be classified into four categories depending upon the study objectives and study endpoints used at different stages. In this presentation, statistical issues and regulatory concerns regarding phase I/II adaptive designs with different study objectives and/or study endpoints are discussed.
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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