Perspectiva general

The pharmaceutical industry has seen a considerable interest and increase in the application of adaptive designs, particularly after the publication of the FDA Draft Guidance on Adaptive Design in 2010.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, uncertainty and questions surround the use of adaptive design. This basic to intermediate level course 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.

Lo que aprenderá

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

Regulatory guidance
Change management/planning implementation
Understand basic statistical concepts needed for Adaptive Trials
Case studies

¿Quiénes deben asistir?

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

Objetivos de aprendizaje

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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