Strengthening the Interface Between Biostatistics and Clinical Practice

Würzburg, Germany – Biostatistics plays a key methodological role in the planning, execution, and analysis of clinical trials. It ensures that reliable conclusions can be drawn from studies and that new therapies are developed safely and effectively.

For this reason, the German Cancer Research Center (DKFZ) and the other partner institutions of the National Center for Tumor Diseases NCT WERA – located in Würzburg, Erlangen, Regensburg, and Augsburg – hosted the international scientific symposium “Biostatistics for Innovative Clinical Trials” at University Hospital Würzburg (UKW) on July 1, 2025.

The NCT is a long-term collaboration between the DKFZ, outstanding university medical centers, and additional leading research institutions across Germany. Its mission is to significantly improve outcomes and quality of life for cancer patients by efficiently translating innovative preclinical discoveries into clinical applications.

Strong Interest Underscores the Importance of Biostatistics in Early Clinical Trials

Around 40 participants from across Germany attended the symposium in person to hear talks by distinguished national and international experts. Another 90 participants joined the event online.

“The strong interest highlights the importance of novel methodological approaches, especially in early-phase clinical trials in oncology,” said Prof. Dr. Peter Heuschmann, Director of the Institute of Clinical Epidemiology and Biometry (IKE-B) at Julius-Maximilians University Würzburg (JMU). Heuschmann co-organized the symposium’s scientific program together with Prof. Dr. Annette Kopp-Schneider of the DKFZ and Prof. Dr. Thomas Jaki of the University of Regensburg (UR).

Focus on PROMs and Dose-Toxicity Modeling

The symposium addressed cutting-edge statistical methods for early oncology trials, including innovative trial designs with their respective advantages and limitations. Key topics also included the use of patient-reported outcome measures (PROMs) and advanced methods for modeling dose-toxicity relationships. A central theme of the event was to foster closer integration between clinical practice and biostatistics in the design and evaluation of oncology trials.

A particular highlight was the interactive workshop, which enabled direct exchange between medical and methodological disciplines. Participants discussed challenges and potential solutions for conducting early-phase trials.

The consensus: early and structured collaboration between clinicians and biostatisticians is critical to the success of future-oriented trial concepts. At the same time, the symposium revealed an ongoing need for better support structures in the oncology research landscape.

Professorship for Biostatistics Planned at NCT WERA

A major step forward is the planned establishment of a professorship for biostatistics at NCT WERA. This new role will help strengthen the strategically important interface between methodology and clinical application and support the continued development of innovative trial designs.

“The symposium was seen by all involved as a great success and has provided valuable impetus for shaping the future of clinical research - both in Germany and internationally,” concluded Prof. Dr. Hermann Einsele, Director of the Department of Medicine II at UKW and spokesperson for NCT WERA.