Enriching in vivo clinical trials with in silico models for orthopedic implants

Abstract

Clinical trials are used by the medical device industry to confirm products safety, performance, and clinical benefits. Traditional clinical studies typically follow a limited number of volunteers, which prevents capturing the full breath of patient demographics and implant use. New tools are required to overcome the limitations of traditional trials while fulfilling increasingly demanding regulatory requirements. Computer simulations have the potential to enrich traditional clinical trials with so called in silico clinical trials (ISCT) by providing data on a much broader spectrum of patients, clinical conditions and implant configurations. The historical use of simulation in the orthopedic device industry is described here to explain how it is now technically possible to model virtual populations. We also discuss the multiple benefits of such a translational research approach for the patients, healthcare systems, and manufacturers, but also the challenges to overcome. A more detailed version is available in English [1].