7. Subgroup Analyses in Early Phase Clinical Trials

Team: Dr Bjorn Bornkamp (Novartis), Prof Werner Brannath (University Bremen)
Clinical Advisor: Prof Bruno Flamion
, a professor of physiology and pharmacology at the University of Namur, Belgium. He is the former chair of the EMA’s scientific advice working party and past chair of the committee for reimbursement of medicines, Belgium.
Location: Novartis Pharma AG (Basel, Switzerland)

Subgroup analyses in early phase trials are frequently conducted, both in a prospectively planned and in a post-hoc manner.In particular the latter situation poses serious challenges for decision makers in their decision whether to proceed a compound to the next phase of development or not.

The aim of this project is to review and compare recent statistical tools in exploratory subgroup analyses to deal with the challenges posed by evaluating multiple models and subgroups, for example in terms of estimates and uncertainty intervals for the treatment effect of a selected subgroup.

In addition the project aims to develop tools for subgroup identification methods beyond the standard cross-sectional setting in two-arm trials (e.g. considering situations with more than two treatments, evolvement over time and more than one endpoint…).

Meet our Early Stage Researcher: Marius Thomas, Novartis Pharma AG

Marius Thomas_new

I was born in Dortmund, Germany. I received my Bachelor in Statistics with Theoretical Medicine as a minor subject at Technical University of Dortmund. I completed my Master in Statistics with a focus on Biometrics in Dortmund as well. For my master’s thesis I dealt with subgroup analysis in clinical trials. During my studies I worked as a teaching assistant at the university and completed an internship at Novartis in Basel, Switzerland. My hobbies include motorsports, playing the piano and reading.



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The IDEAS network brings together leading institutions in the training of medical statisticians, large and small sized pharmaceutical companies and is supplemented by clinical experts.