Session (CTI)

The focus on using real-world evidence (RWE) in regulatory and HTA/payer decision-making has often centered on complex and nuanced use cases like external control arms and comparative effectiveness studies. However, the acceptability of these use cases in decision-making are generally infrequent and involves rare and deadly diseases. While there is a push to advance RWE to more complex use cases (e.g., comparative effectiveness), we often overlook the value of robust descriptive RWE studies to inform clinical development and commercialization. In our experience, the industry often does these RWE studies piecemeal, too late, or not at all. This session will outline a systematic phased approach for RWE investment that is critical for decision-making and the headwinds that arise when companies do not do their critical RWE “homework”. Sponsored by Corporate Partner, Aetion