Economic analysis for in silico clinical trials of biodegradable and metallic vascular stents

Abstract

Today's clinical trials take 10-12years on average to bring a new drug or device to the market, with limited change over the past decades in the linear and sequential process used to assess the efficacy and safety of drugs or devices. InSilc is EU-funded project (www.insilc.eu), which developed the innovative platform and its separate modules that can be used as stand-alone tools for designing, developing, and assessing coronary stents. The world stent market has an estimated value of €6.4 billion, of which 37% is generated in the United States and 10% in the EU. Coronary stents are now the most commonly implanted medical devices, with more than 1 million implanted annually. Coronary stents are currently the most common type of stent used for treating symptomatic coronary disease. In this chapter, the traditional approach for today's clinical trials with only 10% success rate was described. Detailed marker analysis was given with the list of intended users such as Stent Biomedical Industry (stent designers and producers), Contract Research Organizations (CRO), Interventional Cardiologists/Hospitals, Researchers, and Animal Testing Organizations. In this chapter, description of each module was given. Economic analysis described the prices of each module as well as total platform per one stent simulation. The average cost per patient for the execution of a real clinical trial was calculated. The calculated price for in silico trial is lower compared to the price of real clinical trial.