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Activity Number: 380
Type: Roundtables
Date/Time: Tuesday, August 11, 2015 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract #315052
Title: Logistics and Implementation of Adaptive Design Trials
Author(s): Eva Miller*
Companies: InVentiv Health Clinical
Keywords:
Abstract:

It has been more than five years since the release of the FDA Draft Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics. Statisticians will share their experiences implementing these adaptive clinical trials and working with their study teams to adopt the new methodologies, as well as the differences between adaptive trial designs and more traditional trials. Impact on teams and team structures also will be discussed. Newcomers to adaptive trial design are welcome. Questions to be covered include (1) What additional planning, teamwork, software, and communication are required for successful implementation of adaptive trial designs? (2) How do simulations play a role in the development of effective adaptive trial designs? (3) What is required for randomization schemes, drug supply management, clean data, and DMCs within adaptively designed studies?

Authors who are presenting talks have a * after their name.

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