Adaptive Design in Clinical Trials: When and How to Apply On-Demand Training
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Keyword(s)
clinical trial design, Adaptive design, exploratory and confirmatory stages of drug development
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interest and increase in the application of adaptive designs, particularly after the first publication of the FDA Draft Guidance on Adaptive Design in 2010.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.Register Here!
Credit Information
ACPE = 8
IACET = .8
IACET = .8
Description
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