Safety assessment of an implant for clinical research and cardiology
Symptoms of heart failure are often attributed to advancing age and are thus not taken seriously – but heart failure is a serious, life-threatening condition. A particularly high mortality risk is associated with this condition in conjunction with diabetes: between 25 and 50 percent of these patients die within the following 3 to 5 years.
The development of healthcare solutions for people with heart failure is thus of pivotal importance. Only one in ten candidate drugs tested in phase-I clinical trials reach market maturity, at extremely high costs and after a lengthy trial period (up to 15 years). Approved drugs, however, often reveal a lower efficacy in daily healthcare routine than during the clinical trials, a phenomenon referred to as “efficacy-to-effectiveness gap.” The AI-powered exploitation of real-world data – data collected in real-life clinical practice – is aimed at making a significant impact on the real-world eﬀectiveness of treatments for heart failure patients and at the same time leveraging savings in the amount of billions of euros.