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STAT-Net

STAT-Net: Network of statistical experts

Statistical experts across Europe join forces to optimize the design of Phase II and Phase III clinical trials. Trials based on advanced pharmacological modelling and the latest biostatistical and epidemiological concepts.

STAT-Net is a pan-European network of statistical experts from both academia and industry. They share their expertise in pharmacokinetics/pharmacodynamics (PK/PD), modelling, biostatistics, infectious diseases, antimicrobial agents, microbiology, epidemiology and clinical development. With all that knowledge they investigate approaches to improve the data-driven design of Phase II and Phase III clinical trials. STAT-Net projects cover two main topics:

PK/PD studies

Teams in Rotterdam and Bristol perform advanced PK/PD modelling studies to support more extensive use of PK/PD modelling in clinical trial design and future drug development and approval. More specifically, they are:

  • exploring the link between preclinical PK/PD predictions and the observed clinical efficacy and emergence of resistance;
  • developing popPK models to better support the design of Phase II and Phase III trials and better integrate PK data from Phase II and Phase III studies;
  • exploring exposure-response relationships and address PK/PD issues.

Statistical methodologies

STAT-Net is also evaluating novel clinical trial design strategies based on modern biostatistical and epidemiological concepts. Aimed to increase efficiency and success rates of clinical trials. Teams in Zurich, Paris, Freiburg, and Utrecht are:

  • evaluating in depth the use of the hierarchical nested trial design (HNTD) in antibacterial trials;
  • assessing the adaptive use of limited historical control data within a Bayesian framework to shape the clinical development programs of new antibiotics;
  • providing more informative analyses of complex time-to-event patterns that can occur in randomized controlled trials of antimicrobial drugs, by adopting a simulation-based approach;
  • improving the accuracy of endpoints in severe infectious diseases.

Key members

  • Aaron Dane

    Academic / Danestat

  • Alasdair Macgowan

    Academic / Frenchay & Southmead Hospitals (North Bristol NHS Trust)

  • Alexandra McAleenan

    Research physician / Academic / University of Bristol

  • Andrew Lovering

    Scientist / Academic / Frenchay & Southmead Hospitals (North Bristol NHS Trust)

  • Emmanuel Weiss

    Academic / Université de Paris Diderot

  • Femke de Velde

    Pharmacist / Academic / Erasmus MC

  • Harriet Sommer

    MD/PhD student / Academic / Universitätsklinikum Freiburg

  • Isaac Gravestock

    MD/PhD student / Academic / University of Zurich

  • Jean-François Timsit

    Academic / APHP Bichat

  • Jean-Ralph Zahar

    Academic / Université de Paris Diderot

  • Johan Mouton

    Scientist / Academic / Erasmus MC

  • Kit Roes

    Professor / Academic / UMC Utrecht