Adaptive Design in Clinical Trials: When and How to Apply

概要

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in the application of adaptive designs in the pharmaceutical industry, particularly after the publication of the FDA Draft Guidance on Adaptive Design in 2010.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

何を学ぶか

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

学習目的

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

Adaptive Design in Clinical Trials: When and How to Apply

概要

何を学ぶか

参加対象

学習目的

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