Overview

The pharmaceutical industry has seen a considerable interest and increase in the application of adaptive designs, particularly after the first publication of the FDA Draft Guidance on Adaptive Design in 2010.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 virtual training 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.

This on-demand training course takes an average of 8 hours to complete. Learners have access to the course for one year from the date of purchase.

Featured topics

- 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 rrials
- 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

Upon completion of this module, learners 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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Adaptive Design in Clinical Trials: When and How to Apply

Overview

Featured topics

Who should attend?

Learning objectives

Be informed and stay engaged.