The Effective Statistician - in association with PSI
Clinical Development Plans
Oct 28, 2024
In this engaging discussion, Carrie Li, a physician and statistician with over 13 years in the pharmaceutical sector, shares her insights on Clinical Development Plans (CDPs). She highlights the importance of early decision-making and cross-functional collaboration among clinical, commercial, and regulatory teams. Carrie elaborates on the differences between big pharma and startups, adaptive design strategies, and regulatory engagement with the FDA and EMA. Listeners will gain practical tips on balancing scientific rigor with business goals to advance drug development.
35:59
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Quick takeaways
- A Clinical Development Plan (CDP) is crucial for strategic compound progression, requiring early stakeholder engagement to align expectations and objectives.
- Statisticians significantly contribute to CDP by determining sample sizes and analyzing data, balancing scientific rigor with business goals and regulatory requirements.
Deep dives
Understanding Clinical Development Plans
A clinical development plan (CDP) is essential for assembling a strategic framework for any new compound entering human trials. It usually is developed before the compound enters phase one, ideally involving early stakeholder engagement to ensure alignment. A critical component of the CDP is the target product profile (TPP), which outlines treatment effect expectations and desired patient characteristics. This foundation helps guide the progression through phases, adjusting for real-world factors and the competitive landscape for more effective outcomes.
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