Professorship for Medical Biometry with Focus on Clinical Epidemiology

The professorship focuses on methological and biostatistical aspects of clinical research. We deal with deriving answerable clinical questions, developing study design and framework, supervising the progress of clinical trials with biostatistical methods, statistical analysis and communication of results. We investigate own research questions in clinical epidemiology and methodological issues related to dealing with systematic bias and statistical uncertainty.

Research area and projects

Biometry of clinical trials: design and sample size determination for clinical phase 2 and phase 3 trials, especially in oncology, cardiology, and pediatrics

• Operationalization of the scientific question
• Optimization of trial design
• Definition of the statistical design
• Sample size determination
• Planning of interim analyses

Biometry of Clinical Trials: Research on treatment primarily of haematological malignancies

Trial Name	Sponsor	Disease	Indicat.	Phase	Identifier
European MCL 1	Not applic.	MCL	first-line	3	Not applic.
European MCL Younger	Not applic.	MCL	first-line	3	NCT00209222
European MCL Elderly	Not applic.	MCL	first-line	3	NCT00209209
OSHO#70	KUM	FL	first-line	3	2005-005473-29 (EudraCT)
TRIANGLE	KUM	MCL	first-line	3	2014-001363-12 (EudraCT)
MCL R2 Elderly	Lysarc, France	MCL	first-line	3	2012-002542-20 (EudraCT)
R-HAD	KUM	MCL	R/R	3	2005-005144-62 (EudraCT)
ALTERNATIVE	KUM	FL	first-line	2	2014-005164-15 (EudraCT)
ALTERNATIVE-C	KUM	FL	first-line	2	2018-004038-13 (EudraCT)
Gabe2016	KUM	FL	first-line	3	2016-000755-27 (EudraCT)
MCL Elderly 3	Unimedizin Mainz	MCL	first-line	2	2020-002935-30 (EudraCT)
EEN-RICH	KUM	Morbus Crohn	NA	1/2	2022-503027-10-00 (EU CT)
OLYMP-1	Uniklinik Ulm	MZL	first-line or R/R	2	2017-003149-56 (EudraCT)
COUP-1	Uniklinik Ulm	MZL	first-line or R/R	2	2017-003150-16 (EudraCT)
POLE-1	Uniklinik Ulm	MZL	first-line or R/R	2	2018-000187-28 (EudraCT)
CZAR-1	Uniklinik Ulm	WM	first-line or R/R	3	2018-003526-88 (EudraCT)

Not applic. = not applicable; Uniklinik Ulm = Universitätsklinikum Ulm; KUM = Klinikum der Universität München; Unimedizin Mainz = Universitätsmedizin Mainz; MCL = mantle cell Lymphoma; FL = follicular lymphoma; WM: Waldenström's macroglobulinemia;, R/R = relapsed or refractory.

Research on treatment of haematological malignancies

• Long-term follow-up of clinical trials
• Cross-trial comparisons
• Impact of rituximab maintenance for younger patients with mantle cell lymphoma without and with ibrutinib-containing first-line treatment
• Estimation of conditional survival of patients with mantle cell lymphoma
• Impact of different coding variants on frequency estimation for adverse events
• Long-term trends in clinical outcome for patients with mantle cell lymphoma treated in prospective trials

Investigation of clinical and molecular prognostic factors for hematological malignancies

• MULTIlayer Predictive models for relapsed MCL after ibrutinib as first Line therapY (MULTIPLY) in the EuMCLNetwork TRIANGLE phase III trial
• Impact of minimal residual disease (MRD) for estimating prognosis and treatment evaluation or modification in follicular and mantle cell lymphoma
• Prognostic value of histopathological markers in follicular and mantle cell lymphoma
• Clinico-prognostic models for follicular and mantle cell lymphoma
• "Use case indolent lymphoma“ as part of DIFUTURE

Research on biometry and methodology

• New method to estimate clinical outcomes from clinical trials with two-stage randomization
• Comparison of methods to evaluate estimands for treatment effects on overall survival considering subsequent therapies
• Comparison of statistical tests of hypotheses on time-to-event endpoints with fixed time point and stratification
• Evaluation of statistical designs in current oncological phase 2 clinical trials

Data Sharing

• Enabling reuse of data from terminated clinical trials of the German Lymphoma Alliance (GLA) for further clinical and translational research

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