o Process and Stakeholders

• What defines a good process for clinical trial design?
• Compare and contrast a good process with a poor process.
• Who are the stakeholders, and who should manage the design
• process (and why)?
• How are regulatory, clinical, and commercial considerations
• balanced, and who should manage the balancing?

o Study Design and Clinical Endpoints

• How do clinical endpoints influence study design (and vice versa)?
• What are the main drivers of primary vs secondary endpoint
• selection?
• How helpful is the FDA pre-submission process for study design
• and endpoints?

o Case Studies, Real Examples

• Case study examples and key learnings of both successful and not successful clinical trial design