The aim of the webinar is to reflect on the importance to contextualise endpoints and objectives and the associated opportunities for clinical drug development. At the end of a trial it’s often just stated “The trial met it’s endpoint”. However, what about the primary objective of the trial? Are the results relevant for the stakeholders? Is a clear interpretation of the results possible?
The estimands framework as introduced in ICH E9 (R1) offers a systematic approach to design clinicals trials, which are better able to answer the clinical question ultimately leading to a higher probability of success. Potential solutions were presented and assessed.
DATE & TIME
- Tuesday 1 December 2020
- 18:00 – 19:30 (CET) / 12:00 – 13:30 (EST) / 9:00 – 10:30 (PST)
Armin Schueler (Head of Global Biostatistics Oncology, Merck Healthcare KGaA)
Armin Schüler is head of biostatistics oncology and statistical innovation at Merck Healthcare KGaA, Darmstadt Germany. He is a mathematician from training (Georg-August-University, Göttingen). Prior joining Merck he worked in various positions as statistician for companies like Boehringer Ingelheim, Bayer, Quintiles and Hoechst.
Armin’s ambition is to bring statistics to the heart of the decision making enabling data driven portfolio development by an holistic use of all information available.
The webinar was moderated by:
- Mr. Robert Hemmings (Consilium, Salmonson and Hemmings)
- Prof. Axel Glasmacher (CDDF)
- 18:00 – 18-05 (CET): Introduction
- 18:05 – 18:35 (CET): Lecture
- 18:35 – 19:30 (CET): Q&A / discussion session