Daniel Bodden

Daniel
Bodden

Hi there. I'm a biostatistician focusing on clinical trial methodology, especially adaptive designs in small-sample and rare-disease settings, with a particular interest in randomization in these more complex trial designs. I also enjoy teaching and finding simple ways to explain complex ideas.

I built this website as a home for my work, publications, and projects, so collaborators and anyone interested in my research can quickly find up-to-date information. On a personal level, academic research can be competitive and sometimes tough on self-confidence, so having a space where I bring everything together also helps me see the progress I have made.

Publications

Published PLOS ONE · 2025

Randomization in clinical trials with small sample sizes using group sequential designs

D. Bodden, R.-D. Hilgers & F. König

RandomizationGroup SequentialSmall Samples

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In clinical trials, randomization helps ensure participants are assigned to treatment groups in a way that minimizes bias. Group sequential designs allow interim analyses at pre-defined points, making it possible to stop early for success or futility.

We explored how different randomization procedures impact statistical performance (type I error rate and power) in group sequential trials with very small sample sizes.

This paper discusses

▸ How different randomization procedures affect power
▸ How improper design can affect type I error control
▸ A practical framework for choosing a suitable randomization procedure for small sample group sequential trials

Published Orphanet J Rare Dis · 2024

Multi-stakeholder sessions on major innovation topics in rare disease clinical trials

D. Bodden, S. Schoenen, S. Wied, J. Verbeeck, et al.

Rare DiseasesEJP-RDStakeholders

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This paper is the culmination of collaborative efforts within the European Joint Programme on Rare Diseases (EJP RD), specifically Work Package 20, focused on driving innovation in rare disease clinical trials. It captures insights from our April 2023 retreat, where we convened a diverse group of stakeholders — including researchers, patient advocates, clinicians, and industry representatives — to identify key challenges and unmet needs.

What's next

The identified challenges are being addressed in the newly launched projects RealiseD and ERDERA.

Published BMC Med Res Meth · 2025

Randomization in the age of platform trials: unexplored challenges and some potential solutions

O. Kuznetsova, J. Ross, D. Bodden, et al.

Platform TrialsRandomizationChronological Bias

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Accepted Stat Methods Med Res

When randomization is not random: Allocation bias in small-sample group sequential randomized clinical trials

D. Bodden, R.-D. Hilgers & F. König

Allocation BiasGroup SequentialSmall Samples

Under Review Biometrical Journal

Multiple treatment arms, multiple biases? Allocation and chronological biases in rare disease platform trials

D. Bodden, N. Bruder, R.-D. Hilgers & F. König

Platform TrialsAllocation BiasChronological BiasRare Diseases

Internal Review RealiseD

RealiseD: Realising Clinical Trials in (Ultra-)Rare Diseases – Multi-Stakeholder Perspectives on Design, Familiarity, and Implementation

D. Bodden, D. Bonifazi, N. Bruder, F. Koenig, C. Kyriakopoulou, et al.

Rare DiseasesRealiseDMulti-Stakeholder

Peer reviewer: Orphanet Journal of Rare Diseases · PLOS ONE

All publications on ORCID

Let's talk about
statistics.

I'm happy to discuss research collaborations, statistical consulting, speaking opportunities, or just an interesting methods question.

Daniel
Bodden

Randomization in clinical trials with small sample sizes using group sequential designs

Multi-stakeholder sessions on major innovation topics in rare disease clinical trials

Randomization in the age of platform trials: unexplored challenges and some potential solutions

When randomization is not random: Allocation bias in small-sample group sequential randomized clinical trials

Multiple treatment arms, multiple biases? Allocation and chronological biases in rare disease platform trials

RealiseD: Realising Clinical Trials in (Ultra-)Rare Diseases – Multi-Stakeholder Perspectives on Design, Familiarity, and Implementation

Presentations

Invited Talks & Oral Presentations

Conference Poster Presentations

A few things I care about

Tablesoccer / Foosball

Chess

Let's talk about
statistics.

Daniel Bodden

Randomization in clinical trials with small sample sizes using group sequential designs

Multi-stakeholder sessions on major innovation topics in rare disease clinical trials

Randomization in the age of platform trials: unexplored challenges and some potential solutions

When randomization is not random: Allocation bias in small-sample group sequential randomized clinical trials

Multiple treatment arms, multiple biases? Allocation and chronological biases in rare disease platform trials

RealiseD: Realising Clinical Trials in (Ultra-)Rare Diseases – Multi-Stakeholder Perspectives on Design, Familiarity, and Implementation

Presentations

Invited Talks & Oral Presentations

Conference Poster Presentations

A few things I care about

Tablesoccer / Foosball

Chess

Let's talk aboutstatistics.

Daniel
Bodden

Let's talk about
statistics.