The EMET (Evaluation and Modelling with the Therapeutic Effects Group) team, which is part of the Biometry and Evolutionary Biology laboratory (LBBE), works closely with our platform, particularly to optimise the development of therapeutics.
Sample size calculation has become a must in any clinical research project. It is a concrete illustration of how modelling, often being very simple, helps in optimising experimental designs by involving the right number of patients. The considered parameters include statistical risks of false positive or false negative results, the expected size of treatment effect and the variability outcomes on which the effect will be measured.
PK/PD (Pharmacokinetic/Pharmacodynamic) modelling is deeply rooted in pharmacology culture. It has been enriched by the addition of population-based approaches enabling a better grasp of the interindividual variability.
The EMET team is adding disease modelling to this culture, in accordance with phenomenological and mechanistic approaches, so that therapeutics can be modelled in its entirety (drug-disease relationships). The integration of the whole therapeutic model in multiple individual profiles, thereby generating hypothetical or realistic virtual populations, enables the simulation of clinical trials, just like in the CRESIM project. The specific ambition CRESIM has is to help in the choice of experimental design.
The coupling of therapeutic model with realistic virtual population is used to simulate the public health impact (link to article by Ivanny), validate new therapeutic strategies (doi: 10.1371/journal.pone.0017508, doi: 10.1371/journal.pone.0140793) or explore new avenues/therapeutic targets (http://www.novadiscovery.com/).