Free Webinar:
Overview of regulatory principles and practice of adaptive design
The draft publication of ICH E20 for Adaptive Design is a landmark achievement in the regulatory acceptance of adaptive designs in clinical trials. ICH E20 provides an overview of the key principles of adaptive design while providing an overview of the most common types of adaptations and also signposting some common areas of special interest (and potential future development).
In this free webinar, Ronan Fitzpatrick, Lead Statistician at nQuery, will prodivde an overview of adaptive design regulatory guidance, a breakdown of the key principles and design considerations covered in ICH E20 and provide a preview of areas which may potentially change between the draft and final guidance.
Learning objectives:
In this free webinar, you will learn how to navigate the complexities of adaptive design in clinical trials, empowering you to implement methodologically sound and regulatory-aligned studies.
Key Areas Covered:
1. Overview of Adaptive Designs and Regulatory Guidance
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Understand the current regulatory landscape for adaptive designs, including the significance of the draft ICH E20 publication.
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Recognize how a unified regulatory approach supports the appropriate use of adaptive designs and encourages consistent trial integrity.
2. Key Principles for Adaptive Design in ICH E20
- Learn the fundamental principles that ensure adaptive trials are well-designed, reliable, and answer clinical questions efficiently.
- Explore common types of adaptations such as early stopping, treatment selection, and sample size re-calculation.
- Understand special considerations including adaptive time-to-event trials, simulation methods, and Bayesian approaches.
3. Special Topics of Interest in ICH E20
- Identify areas highlighted for special attention or potential future development within the guidance.
- Recognize how stakeholders can contribute during the comment period to maximize the impact of the final guidance.
4. Practical Implications for Clinical Trials
- Understand how adaptive design can accelerate trials while maintaining scientific rigor.
- Appreciate how regulatory guidance helps ensure trials are both efficient and ethically sound.
About nQuery
nQuery helps make your clinical trials faster, less costly and more successful. So if you need something more than just a sample size calculator, nQuery is an end-to-end platform covering Frequentist, Bayesian, and Adaptive designs with 1000+ sample size procedures.
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