Phase I Trials: Establishing Proof of Concept
Why You Should Attend
- Implement new ideas to overcome challenges and roadblocks in getting to proof of concept in Phase I.
- Determine how implementation of biomarkers early in the clinical development program will benefit
your study. - Uncover what type of safety assessments to include in the Phase I protocol, based on preclinical findings.
- Acquire the tools to design early stage trials for maximum information.
- Learn how new technologies help trial sponsors move through Phase I faster.
- Explore the practical issues associated with QT studies and whether QT studies are the only way to show cardiac safety.
- Identify strategies to overcome the difficulty in recruiting patients for Phase I.
- Understand the differences in ethical issues with volunteers versus patients.
- Define best practices to work successfully with your sites and ensure on site safety.
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