Upcoming seminars

Monday, November 05, 15:15

Lars Endahl and Henrik Ravn
Biostatistics, Novo Nordisk A/S
Estimands and missing data - two hot topics in the pharmaceutical industry

A 2012 report commissioned by the US Food and Drug Administration (FDA) on the prevention and analysis of trial results in the presence of missing data, has recently lead to significant changes in the clinical drug development. The report also introduced estimands as a new concept - a concept elaborated on in recently updated statistical guidelines for the pharmaceutical industry (the ICH-E9(R1) still in draft). The focus of the ICH-E9(R1) guideline is to discuss how intercurrent events, such as death or discontinuation of the randomised trial product can be embraced in the estimation of a treatment effect rather than just seen as a source of bias. In this talk we will outline how the estimand concept and the focus on prevention of missing data have changed the way clinical trials for new drug approvals are designed and conducted, how the data is analysed and how the results are communicated.

Map of CSS

You can find CSS next to the Botanical Garden, 5 minutes from Nørreport station.

Meeting room 5.2.46 is the library of the Biostatistics section, located in building 5, 2nd floor, room 46. See the map below for directions inside CSS.