Start / The Effective Statistician – in association with PSI / Clinical development plans

The Effective Statistician – in association with PSI

Clinical Development Plans

36 min • 28 oktober 2024

Interview with Carrie Li

Key points:

Clinical Development Plan (CDP): strategy for compound progression
Early Decisions: impact on clinical phases, timeline, cost
Statistical Role: balancing science, speed, and cost
Target Product Profile (TPP): guides CDP objectives
Cross-functional Collaboration: clinical, commercial, regulatory teams
Big Pharma vs. Startups: differences in resources, risk, investor expectations
Adaptive Design: flexibility in clinical phases, risk management
Regulatory Engagement: early involvement of FDA, EMA for approvals
Competitor Landscape: use of competitive intelligence for CDP design
Cost & Timeline Estimation: sample size, Gantt chart for budgeting

Together, we explore how to balance scientific rigor with business goals, collaborate across teams, and navigate the regulatory landscape to bring new therapies to life. Carrie shares practical advice and insights that can help anyone involved in drug development make a real impact.

Don’t miss this conversation—listen to the full episode, and if you find it valuable, share it with friends and colleagues who are passionate about advancing healthcare.

Senaste avsnitt

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