Project Details
Projekt
Adaptive (seamless) designs for real-time evaluation of diagnostic tests and their usefulness for the parameterisation of dynamic infection spread models in epidemic and pandemic settings
Subject Area
Epidemiology and Medical Biometry/Statistics
Term
since 2021
Project identifier
Deutsche Forschungsgemeinschaft (DFG) - Project number 458526380
During an epidemic or pandemic, the early and reliable diagnosis of an infection is not only essential for determining the disease status of an individual, but also for the model-based evaluation of the effectiveness of infection control measures at population level. For emerging infections like SARS-CoV-2, new diagnostic tests have to be developed during the early phase of the epidemic or pandemic, and their accuracy needs to be evaluated within a tight period. Therefore, the acceleration of research for innovative diagnostic tests is a central goal. This will be of even higher importance once the amendment of the national medical device law in the EU will be put in practice, and new standards for the regulation of diagnostic tests will be implemented.This interdisciplinary project combines two research areas: Adaptive (seamless) designs for diagnostic studies, which enable modifications during the course of a trial and thereby speed-up the development of diagnostic tests, and dynamic mathematical models, which use realistic infection spread concepts as a basis for the simulation of interventions. A correct parametrisation of basic epidemiological measures in these models is crucial for the interpretability of model results. These parameters are directly derived from aggregated results of diagnostic tests, and have to take the diagnostic accuracy of the respective tests into account.The aim of this project is to create a flexible study concept for the accelerated development of diagnostic tests that can support real-time modelling of infectious disease dynamics in the case of an epidemic or pandemic. The developed concept will result in earlier and better evidence for the decision for or against infection control measures to contain the epidemic or pandemic and will help to minimize the human and economic damage. The results will be prepared in such a way that they can be easily implemented in case of future epidemics or pandemics. For this purpose, guidance documents will be written, which contain flow charts, study designs and models with the corresponding explanations. Furthermore, all methods will be implemented in a user-friendly way in open source software and their application will be explained.
DFG Programme
Research Grants
International Connection
Austria, Denmark, Netherlands
