Whitepaper

Estimands – Opportunity or Risk for Drug Developers?

Learn how the estimand framework can sharpen trial objectives, reduce regulatory risk, and deliver results you can trust.

Discover how the estimand framework can transform your trial design, reduce regulatory risk, and deliver more reliable results.

In a fast-changing regulatory landscape, one concept is reshaping how clinical trials are designed and analyzed: estimands.
For many sponsors, they remain a grey area, causing unclear objectives, costly redesigns, and avoidable delays.
This white paper cuts through the complexity and shows you exactly how to apply the estimand framework to build better trials, align with regulators, and accelerate your path to approval.

Key Takeaways

Understand the estimand framework and its critical role in aligning study objectives, design, data collection, and analysis.
Explore strategies for handling intercurrent events (ICEs) to improve data integrity and reduce bias.
Learn how estimands impact regulatory interactions and why early integration can prevent costly delays.
See the opportunities and risks from enhanced transparency with stakeholders to the increased statistical complexity of certain strategies.
Discover simulation-guided design with KerusCloud® to optimize endpoints, sample sizes, and trial efficiency.

Every trial decision you make today influences tomorrow’s success. Equip your team with the knowledge to navigate estimands confidently and maximize the value of your clinical data.