LAUSR

It is common for pharmaceutical companies to consider evidence generation as the responsibility of individual departments (e.g., clinical development, medical affairs and health economics and outcomes research). This typically means that evidence is generated in a sequential fashion; for example, waiting for regulatory approval before initiating an outcomes-based study. This is a relatively risk-averse strategy that has served the industry well in generating evidence to satisfy regulatory and reimbursement decisions, and until recently, there has been little need to improve it. An integrated approach to evidence planning that involves the bringing together of randomized clinical trial (RCT)and real-world evidence (RWE)-based approaches across all departments offers an innovative operating model. It benefits industry by generating the RWE required to meet the increasing demands of decision makers, and benefits patients by generating value-based outcomes that translate into clinically meaningful effects in the real world. There are many components that can be informed by RWE when establishing an integrated evidence strategy and optimizing evidence generation. Here, we focus on end point strategy, Phase III population identification, RCT recruitment, patient-reported outcomes (PROs), outcome agreements and effectiveness prediction.