University Medical Center Utrecht
Description
The University Medical Center Utrecht 
is an internationally renowned university research and teaching hospital with 1,200 beds, more than 10,000 staff and all medical specialties represented. The Julius Center for Health Sciences and Primary Care employs over 400 researchers engaged in clinical research and epidemiology. It includes a strong tradition in theoretical epidemiology and biostatistics and has a sizeable unit of Biostatistics with focus on clinical trials, meta-analysis and prognostic modeling. Research ethics is uniquely embedded in the Julius Center, facilitating integration of ethical perspective from design to execution of clinical research.
Main tasks
The UMCU main tasks include first of all statistical methodology development and simulation studies, specifically on sequential meta-analysis and combination of Bayesian and frequentist approaches for both individual clinical trial design as well as series of trials, in WP3. UMCU will also provide input to statistical methodology development on randomization strategies, standards of evidence and adaptive strategies with multiple endpoints in WP2. Clinical expertise and concrete clinical trials in relevant, small sample diseases, most notably in children, oncology, amyotrophic lateral sclerosis (ALS) and tuberous sclerosis complex (TSC) will be provided for validation in WP5. The UMCU will participate in evaluation/validation of methods against these as well as regulatory case studies. UMCU will also investigate the ethical perspective related to trial designs and patient involvement approaches in WP4 and participate in full in dissemination of results (WP6). Finally, UMCU will lead the overall management of the project (WP1).
Key personnel
Prof. dr. Kit Roes is the principal investigator. He is professor of Clinical Trial Methodology at the Julius Center of the University Medical Center Utrecht. He leads the methodology group as part of the UMC Utrecht clinical trial center. His present research focus is on design and analysis of clinical trials, with an emphasis of innovative designs and bridging the gap between clinical trials and real world evidence. He participates in the Regulatory Science Network Netherlands and is advisor to the Dutch Medicine Evaluation Board. His experience includes over 15 years in research and development in the pharmaceutical industry and life sciences, serving clinical research and drug development as expert as well as in different (international) senior management positions.
Dr. Rieke van der Graaf studies ethical issues of innovative trial designs such as adaptive and cluster randomized trials, voluntary informed consent and issues of international justice in research. She is lecturer of Medical Ethics and serves in various (international) ethical committees.
Dr. Caroline van Baal is an expert in genetic epidemiology using twin and family designs. She advises on methodology of clinical trials in the UMC Utrecht and participates in a number of Data and Safely Monitoring Boards. In addition to her scientific work for Asterix, she is the Project Manager.
Dr. Stavros Nikolakopoulos is a statistician with a specialization in the design and analysis of clinical trials. His research focus is on the combination of Bayesian and frequentist approaches for the design of small clinical trials. He has experience in statistical consultation and collaboration with medical researchers in the field of rare neuromuscular disorders.
Dr. Katrien Oude Rengerink is a methodologist and was involved in the design, conduct, analysis and reporting of multiple multicenter trials in Obstetrics and Gynaecology, mostly focused on induction of labour and urinary incontinence treatment. She is an expert in embedding trials in evidence-based clinical practice.
Konstantinos Pateras is a PhD student, specialized in Bayesian statistics with regard to clinical trials in small populations.
Marian Mitroiu is a PhD student, specialising in clinical trials methodology.
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Prof. dr. Kit Roes |
Dr. Caroline van Baal |
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Dr. Rieke van der Graaf |
Konstantinos Pateras, PhD student |
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| Dr. Stavros Nikolakopoulos Researcher, WP3 |
Dr. Katrien Oude Rengerink |
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| Marian Mitroiu, PhD Student Researcher, WP5 |
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