Misselwitz_frank

NEW APPROACHES TO EVIDENCE BUILDING IN MEDICINE: THE INDUSTRY PERSPECTIVE

Our current model of evidence generation is still based on the classical sequence of phase I to III randomized clinical trials (RCT) that (in cardiovascular medicine) generate population based highly generalizable data. In some cases risk enrichment strategies are utilized. Considering CV outcomes trials, this has led to very large and costly RCTs with fully-loaded cost per patient at a level of 26-30 k€ in CV and cost approaching 200 k€ in oncology trials. This model may no longer be sustainable going forward. There are several options to address this problem: Large and simple clinical trials; randomized registries and other approaches.

 

Our industry nowadays redefines the role of external innovation, and particularly the – Industry – ARO and industry – CRO partnerships. The main and fundamental questions to be answered in this context are: “How to switch from a provider of new drugs to a provider of new healthcare solutions?” and also “How to transform cardiovascular medicine into a more personalized precision medicine?”

 

The talk will address the role of deep phenotyping and genotyping, big data analytics and systems biology and innovative ways of adaptive trial designs.