TL1: Best Practices for Adaptive Trial Designs
*Eva Miller, Senior Director, Biostatistics inVentiv Health Clinical Keywords: Adaptive Trial Designs, Implementation of Adaptive Trials It has been almost 5 years since February 2010 and the release of the FDA Draft Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics. Utilization of adaptive designs within industry seems to have plateaued. What are some of the barriers? How can these barriers be overcome? Statisticians who would like to share some of their experiences in implementing these adaptive clinical trials and working with their study teams to adopt these new methodologies will discuss their experiences and the differences between adaptive trial designs and the more traditional trials. Impact on teams and team structures will also be discussed. Newcomers to adaptive trial design are welcome. This year, the DIA Adaptive Designs Working Group formed the Best Practices Working Group. We will also discuss that project, what we are learning, and answer these questions: When is it advantageous to utilize adaptive trial designs? What are best practices for implementation of adaptive trial designs?
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Key Dates
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November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
Housing Deadline -
September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC