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Clinical trial methodology & statistical consultation

Biostatistics, Intervention research, Trial innovation

Research aim

We develop, evaluate, and apply innovative clinical trial designs and sound statistical methodology to efficiently obtain high-quality evidence on healthcare interventions, ultimately optimizing patient outcomes

About us

Well-designed clinical trials with sound statistical methodology are key to generating high- quality evidence on the efficacy, effectiveness and safety of healthcare interventions. Innovations in clinical trial design and methods for analysis are needed to ensure efficient use of resources in an era of increasing healthcare costs and focus on patient-tailored interventions. Our current research topics in this area include, for instance, adaptive trials, platform trials, basket trials and trials-within-cohort studies. We also develop and evaluate statistical methods for incorporating external or real-world data in analysis of trials and methodology for combining multiple endpoints based on patient preferences.

Designing and analyzing clinical trials comes with specific challenges, making it important to involve the right statistical expertise early on in the grant writing stage. We can advise on the best study design, sample size and statistical methods. In later stages, we write statistical analysis plans and perform or support statistical analyses. We collaborate with researchers across all strategic themes of the UMCU as well as researchers from other medical centers. We offer general statistical support through Julius Support, participate in the U-TRIAL alliance and collaborate with the Dutch Medicines Evaluation Board.

Reach out to us when you plan to design a clinical study. We are happy to collaborate!