Medizinische Hochschule Hannover
Hannover Medical School (MHH) is one of the largest university medical centers in Germany with 1,500 beds and more than 70 clinics and institutes. The Institute of Biostatistics is in charge of teaching medical students, providing biostatistical advice to doctoral theses, research projects, and especially for supporting the conduct of clinical trials at Hannover Medical School (MHH). Biostatistical methodology for drug trials, therapeutic trials and diagnostic trials, as well as meta-analyzes are the main focus of research. MHH is one of the largest transplant centers in Germany and in the field of transplant medicine and post-transplant disease is by definition, orphan. The Institute is involved in the planning of clinical trials in very rare diseases,
MHH Biostatistics department has substantial experience in planning trials in rare disease and has identified key problems for further methodological research. In WP2, MHH wants to contribute to the development of standards for adaptive generation of evidence, randomization methods for clinical trials in small populations, and methods for combination of endpoints. Simulation studies, theoretical considerations and considerations from the experimental design perspective will be utilized. In WP3, MHH will contribute simulation studies to comparing multiple studies with concepts, where only one pragmatic study per research question is planned and conducted. In WP5, MHH will contribute with scenario simulations with input from (blinded) real-life data from clinical trials. In WP6, MHH will (beyond publishing articles in relevant journals) bring research into the regulatory discussion about requirements for trial design in drug licensing for orphan drugs.
The PI and head of institute, Prof. dr. Dr. Armin Koch, has been involved in the development of regulatory guidelines for many years and contributes to finding commensurate rules for drug development in rare disease. He has been involved in the discussion of the European Points of Consider Document on Applications with (i) Meta-Analysis and (ii) one pivotal trial (CPMP / EWP / 2330/99), is one of the main authors of the European Reflection on Confirmatory Clinical Trials with Adaptive Design (CHMP / EWP / 2459/02) in the context of evidence for drug licensing on safe grounds (ie without lowering) of regulatory standards). Currently he is one of the authors of the European Guidance document on assessment of subgroups of clinical trials.
Local organization of ASTERIX conferences, reporting and dissemination was done by Armin Koch, Anika Großhennig and Lukas Aguirre Dávila with support of the researchers Stefanie Ernst, Theodor Framke, Eva Jenz, Annika Karch, Martina Kottas, Florian Lasch, Andrea Smith, Loukia Spineli, Kristina Weber, Yvonne Ziert.