Webinar: Accelerate Early Clinical Development with Adaptive, Multi-Part, First-in-Human Study Design
In early clinical development, making changes to a study design after regulatory approval can cause significant delays. These can be avoided by incorporating additional/optional study parts into the original protocol. Proactively planning for additional study elements gives greater flexibility, allowing you to make decisions based on emerging data, without requiring additional regulatory approval.
With extensive practical experience and scientific knowledge of the design, management, analysis and reporting of early clinical development projects, including first-in-human pharmacology, phase I pharmacology and pharmacokinetic (PK) studies, join Dr. Simon Hutchings and Dr. Danielle Francome on this webinar to get insights on:
- How to work with your CRO to create an adaptive, multi-part FiH study which suits your needs
- Adding maximum value to your FiH protocol by answering key human pharmacology questions via flexible and optional study parts (e.g. food effect, DDI, formulation, posology, target engagement, gender/age effect, TQT assessment, Proof of Concept)
- Additional considerations for FiH to patient multi-part studies
- Theoretical and case study examples
- Considerations for budgeting