Development planning, including modeling study cost, is critical to the success of any product. A rigorous methodology based on research done with the FDA and a large pharma exists for objectively and quantitatively modeling and understanding study cost, including studies with biomarkers. Guided by this modeling, the clinical development strategist can revise study strategy to save money while preserving objectives.

Learning Objectives:
Discuss how to capture study design uncertainty as base case, best case, and worst case
Explain how to assign cost to specific components of study design
Evaluate study design features and cost to understand how to maintain study objectives while potentially lowering the study cost.