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Clinical trials for personalised, marker based treatment strategies

Research Objectives:

Molecular biology promises highly personalised medicine in future, where optimal treatment options are chosen based on characteristics of the patient and his/her disease. However, as any other new treatment, such strategies have to demonstrate their superiority over the current standard treatment in randomised clinical trials before they can be recommended for all patients. Due to the limited information on single markers and in particular on combinations of multiple markers, any strategy chosen in such a trial might be suboptimal and some patient groups might not benefit at all. Hence a simple comparison of the new strategy with the current standard is not sufficient. We need methods to select a subset of patients with proven, increased efficacy.

Description of work:

The main tasks of the project are to translate the need described above to well-defined statistical problems, to develop and compare statistical approaches to solve the problems and to develop recommendations for the analysis of such trials in future. We will build on methodology for sequential estimation and testing, adaptive trials, subgroup and interaction analyses, multiple testing and the current approaches to clinical trials using information from a single marker. All approaches should allow incorporating prior clinical knowledge on markers and targeted therapies and in particular on their interactions with respect to efficacy and safety. The output of this project will be relevant for all clinicians and statisticians involved in the planning and analysis of studies on personalized treatment strategies, both in industrial as well as academic settings.

Host Institution: University Medical Center Freiburg

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