Detail

Keywords

Biostatistics; Clinical Trial; Models, Statistical; Randomized Controlled Trial

Research interests

My research is centered on the development and application of innovative clinical trial designs, such as platform trials, group sequential trials, adaptive designs, and multiple testing procedures. My primary aim is to enhance statistical frameworks to optimize their design and accuracy, thereby supporting more reliable and robust outcomes in medical research. An important area of application of these designs is clinical trials in rare diseases or vulnerable populations, such as in pediatrics. A significant aspect of my work involves the integration of these innovative designs in pivotal clinical trials, which are crucial for the approval process of new drugs. Additionally, as a member of the Methodology European Specialised Expert Community at the European Medicines Agency, I contribute to the development of guidelines that underpin these crucial scientific advancements."

Techniques, methods & infrastructure

The development of advanced clinical trial designs is achieved through a combination of methods. This includes analytical derivations, numerical optimization, and comprehensive Monte-Carlo simulation studies to assess the properties of these designs. Key tools in this process include statistical modeling, utilizing both Frequentist and Bayesian approaches to enhance the efficiency and robustness of clinical trial designs.

Grants

• Innovative designs, extrapolation, simulation methods and evidence-tools for rare diseases addressing regulatory needs (INVENTS) (2023)
  Source of Funding: EU, Horizon
  Principal Investigator
• Sharing and Re-using clinical trial data to maximise impact (Share-CTD) (2023)
  Source of Funding: EU, Horizon-MSCA
  Principal Investigator
• IMPROVE-PSP (2020)
  Source of Funding: EU, EJP RD - European Joint Programme on Rare Diseases - Clinical Trials Methodology Demonstration Projects
  Principal Investigator

Selected publications

1. Koenig, F., Spiertz, C., Millar, D., Rodríguez-Navarro, S., Machín, N., Van Dessel, A., ... & Posch, M. (2024). Current state-of-the-art and gaps in platform trials: 10 things you should know, insights from EU-PEARL. eClinicalMedicine, 67.
2. Roig, M. B., Krotka, P., Burman, C. F., Glimm, E., Gold, S. M., Hees, K., ... & Posch, M. (2022). On model-based time trend adjustments in platform trials with non-concurrent controls. BMC medical research methodology, 22(1), 1-16.
3. Ballarini, N. M., Burnett, T., Jaki, T., Jennison, C., König, F., & Posch, M. (2021). Optimizing subgroup selection in two‐stage adaptive enrichment and umbrella designs. Statistics in medicine, 40(12), 2939-2956.
4. Bretz, F., Koenig, F., Brannath, W., Glimm, E., & Posch, M. (2009). Adaptive designs for confirmatory clinical trials. Statistics in medicine, 28(8), 1181-1217.
5. Bretz, F., Maurer, W., Brannath, W., & Posch, M. (2009). A graphical approach to sequentially rejective multiple test procedures. Statistics in medicine, 28(4), 586-604.