Estimands in Safety Analytics

The value of well-defined safety estimands is not generally appreciated and has not been communicated well to safety scientists. 

• Safety analyses are often ambiguous and, in some cases, carry the risk of being misinterpreted.

• A better understanding and consequently a more consistent application of a robust estimand framework in the analysis of safety data would eliminate this ambiguity and drive clarity on both the specific question an analysis addresses, as well as the answer to that question.

• Develop a user-friendly, one-stop education portal on the topic of safety estimands.

• Encompass and reference the learnings and recommendations of other external groups working on safety estimands – work in a complementary and comprehensive fashion, and ensure information is presented in a digestible, fit-for-application manner.

• Develop an education series with the goals of (1) substantially increasing the comfort level of safety scientists when articulating appropriate safety estimands (2) increasing their use in practice and (3) increasing the breadth of estimators routinely used in safety analytics.

Michael Colopy, Polaris Data Labs

mike@polarisdatalabs.com

Andreas Sashegyi, Lilly

aisasheg@lilly.com  

Nicola Newton, PHUSE Project Coordinator

nicky@phuse.global 

Series of Training Modules

TBC

White Paper

TBC