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Bethesda North Marriott Hotel and Conference Center

Apr 08, 2019 8:30 AM - Apr 08, 2019 12:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Short Course 1: New Adaptive Design Guidance

Overview

Short Course Registration: 7:30-5:30PM

In this short course, we will describe the new FDA draft guidance on adaptive designs. The 2018 document, which replaced the 2010 draft, provides guidance on the appropriate use of adaptive designs for clinical trials to provide evidence of the effectiveness and safety of a drug or biologic. We will describe the key principles for designing, conducting, analyzing, and reporting the results from a clinical trial with an adaptive design. We will also address a number of special topics, such as the use of simulations in adaptive design planning and the use of Bayesian adaptive design features.

Learning objectives

At the conclusion of this short course, participants should be able to:
  • Define an adaptive design and discuss important advantages and limitations of adaptive designs
  • Describe four important principles for clinical trials with an adaptive design
  • Provide examples of the types of design modifications that can be incorporated into an adaptive design
  • Outline the types of information FDA needs to evaluate an adaptive design and to evaluate results from a trial with an adaptive design
  • Discuss special considerations in adaptive design, including the use of simulations, the use of Bayesian features, adaptations in time-to-event settings, and adaptations based on a potential surrogate or intermediate endpoint

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