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Clinical Trial Simulation course at University of Lyon

The session started by explaining the value of Clinical Trial Simulation, using the excellent video from Roche. Afterwards, we used Simulo on Web to play with a Sunitinib PK model. Simulating a single profile allowed the students to understand how the model behaves. By changing the model parameters, they gain insight in how a different absorption rate or volume of distribution can change the shape of a concentration-time curve. In a next step, we activated inter-individual variability and simulated multiple subjects. By searching for a dose that put 90% of patients in the therapeutic window, they now also understand that a single dose will still result in different PK for each subject. Afterwards, we moved to Clinical Trial Simulation. Through carefully selecting the times of observation, they managed to approximate the AUC using the trapezoid method with only 10 timepoints. Finally, simulating multiple trials allowed students to understand Probability of Success simulations. In our case, 7 out of 16 students achieved biosimilarity to the originator, while the other 5 did not achieve biosimilarity. A risky trial design indeed!

SGS Exprimo values the collaboration with the University of Lyon, both in teaching and research. "Sharing our experience in a workshop with university students sharpens our skills as consultants. It allows us to reflect on the essence of what we are doing, and realign with the theory and methodology.", reflects Ruben Faelens, Scientist at SGS Exprimo.

The University of Lyon appreciates this partnership. "Inviting industry to teach in our course provides an extra dimension. Students learn that these methods are not simply academic, but are actually applied in drug development."

We are both looking forward to next year!

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