In this webinar, Paul Terrill, Associate Principal of Strategic Consulting at Cytel,will share the bottom-line on estimands and discuss their implications for your trial’s data collection, statistical analyses, and conclusions. Paul will also share his guidance on managing the communication about estimands between multiple internal stakeholders as well as regulatory agencies, gaining internal buy-in, and ensuring that your trial demonstrates integrity in line with the ICH E9 addendum.
Key Learning Points
- Estimands and their role in clinical trials- the essentials
- Which stakeholders need to understand them and why?
- Why it is not just a statistical issue
- How do estimands impact:
Internal understanding and agreements
The clinical data collected
The statistical analyses
The conclusions from the study
The Regulatory approval process - How to facilitate early discussions with clinicians and regulators to harmonize trial objectives
- The consequences of not thinking about estimands
- Best practices for organizations
Audience
Medical
Clinical Development
Clinical Operations
