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Oct 21, 2014 8:00 AM - Dec 31, 2050 12:00 AM

Adaptive Design in Clinical Trials: When and How to Apply

Overview

There has been a considerable interest and increase in the application of adaptive designs in the pharmaceutical industry, particularly after the publication of the FDA Draft Guidance on Adaptive Design in 2010. Adaptive design has the potential to reduce the cost and length of drug development, and/or improve the probability of success and de-risk drug development. However, there is a lot of uncertainty and questions around the use of adaptive design. In this course we will identify opportunities in early and late phase development where adaptive design may be applied, and use practical examples to demonstrate how to appropriately design and implement such trials in consensus with FDA Guidance.
Course Level: Beginner/Intermediate

What you will learn

  • Traditional clinical trial designs at exploratory and confirmatory stages of development
  • Definition of an adaptive clinical trial
  • Different types of adaptive designs
  • Rationale for adaptive trial designs
    • Myths and myth busters
    • Advantages and disadvantages
  • Different types of adaptive designs
  • Regulatory guidance
  • Change management/planning implementation
  • Statistics
  • Clinical development program simulations
  • Case studies

Who should attend?

This course is designed for senior management professionals working in the pharmaceutical and biopharmaceutical industry, including regulatory affairs professionals, clinicians, statisticians and program managers.

Learning objectives

At the conclusion of this course, participants should be able to:

  • Explain the principles of adaptive design
  • Describe the regulatory requirements for adaptive design at exploratory and confirmatory stages of development
  • Recognize situations when adaptive design is applicable, and assess whether an adaptive design is the best solution
  • Outline the infrastructure and processes required for optimal delivery of adaptive clinical trials
  • Discuss  the practical aspects of designing and implementing adaptive design trials

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