Melanie Wright, Sue McKendrick, Nanco Hefting, Rikke Mette Agesen, Helle Lynggaard.
Bringing estimands to life through a real case study. A year on after the final ICH E9 estimands addendum was published, we bring estimands to life from a real example from protocol to press release. Members of the estimands Implementation Working Group (EIWG) will describe the background and study objectives, intercurrent events of interest and chosen estimands in the PIONEER study.
Who is this event intended for?
Anyone working in clinical trials: Clinician, Regulator, Investigator, Academic, Ethics Committee, Statistician.
What is the benefit of attending?
Understand how to describe clinical objectives using the estimands framework, recognising the benefits of this approach.
04:49 Learning Outcomes
06:18 Introduction to the Estimand Framework
08:12 Soup Analogy
10:38 The Estimand Attributes
11:31 Estimand, Estimator and Estimate – the What, How and Numerical Result
13:29 The Story of PIONEER 1 (Novo Nordisk Diabetes Study)
17:12 Pioneer Patient Journeys
18:36 Intercurrent Events Impact the Interpretation of Outcome
25:02 Estimand Examples: (1) Confounded / Reality and (2) Pure / If Only!
38:40 Discussion: Rationale for Choice of Estimands
47:43 Are Different Stakeholders Interested in Different Questions?
53:00 Discussion: Considering Different Points of View
58:47 Conclusions and Recap Learning Outcomes
1:03:23 Q & A Moderated by Nanco Hefting with presenters (Melanie Wright, Sue McKendrick) and NovoNordisk panelists (Rikke Mette Agesen and Helle Lynggaard)