DIA EUROPE 2020

Over the last 5 years we have seen an unprecedented interest in using evidence generated from data collected from clinical practice to support regulatory, HTAs, payers and healthcare providers’ decisions. Such real world evidence (RWE) can be valuable to patients, especially when included in medical product labeling, as it reflects the use of medications in regular clinical practice and can inform patients of what they can expect while on treatment. Much has been written about challenges related to data access, data quality, best practices for curating and linking data, the need to define “fit-for-purpose” data, and appropriate study designs and analytical approaches. However, reaching consensus on how to move forward with the utility of RWE for regulatory decision making seems elusive. The rapidly advancing science and technology require that more subject matter experts and diverse stakeholders collaborate and come to consensus on appropriate standards and tools to help improve the reliability and acceptability of real world evidence to key decisions makers. In this session we will explore how, in this environment, can we leverage multi-stakeholder collaborations to develop broadly accepted solutions. We will consider two examples: The IMI GetReal Initiative and its efforts to form a self-sustainable entity, and a US based RWE collaboration. In 2017 Duke-Margolis Center for Health Policy formed in the US a multi-stakeholder RWE Collaborative with an aim to develop consensus driven white papers for select key topics. We will present select outcomes of the IMI GetReal Initiative and the Duke-Margolis Collaborative’s efforts and focus our discussion on how the work of both can be integrated into global efforts related to the utilization of RWE