Estimands: Treatment Strategies For Handling Intercurrent Events

Estimands have become an increasingly hot topic for statisticians within our industry.

The ICH E9 R1 addendum is entitled ‘Estimands and sensitivity analysis in clinical trials’ and is expected to be finalized in the coming months. Pharmaceutical companies, regulatory agencies and CROs are working in implementing this addendum into their working practices.

It is a time of learning and change for all.

This Whitepaper explores the Estimands framework and its implementation and will provide you :

• An introduction to what Estimands is and it's relationship with Intercurrent Events
• The four elements of the Estimands framework
• A detailed explanation of each Treatment Strategy that includes, Treatment Policy, Composite, Hypothetical, Principal Stratum and While on Treatment
• A guide on how to construct Estimands
• The impact of Estimands on Missing Data, its definition and methodology