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Concepts and Methods to Improve Validity of In Silico Trials – Experiences from Clinical Practice

Forum Details

Date: July 15, 2022 12-1 PM Eastern time

Speakers: Doris Fuertinger, Ph.D., Director Biomedical Modeling and Simulation at Fresenius Medical Care

Realistic simulations of clinical trials can provide valuable information regarding safety and limitations of treatment protocols and have been shown to be vital for the cost-effective planning of clinical studies. Monte Carlo sampling and re-sampling techniques are frequently used to create virtual populations for this purpose. While conceptually attractive, Monte Carlo simulations may fall short in representing the (patho)physiology of an actual individual subject, because, in general, only population-wide characteristics are represented. We show how patient-level data can be used to create large cohorts of individual virtual representations of patients (“Avatars”) and improve on external validity of Virtual Clinical Trials (VCT). Further, we will touch on the topic of ecological validity of VCTs. We exemplify this approach in the context of model-based in silico clinical trials aimed at anemia treatment and treatment of secondary hypoparathyroidism in hemodialysis (HD) patients.