Since The 21st Century Cures Act was signed into law in 2016, life science companies and real-world data (RWD) companies have been exploring ways in which real-world evidence (RWE) can be used for regulatory decision-making. Yet despite the number of Draft Guidance documents that the FDA has published on this topic in recent years, examples of RWE used for regulatory purposes are few and far between.

However, there are a range of study types leveraging RWD which can inform both life science companies and regulatory agencies on the use and outcomes of new therapies in real-world settings. On the continuum, use cases range from contextual information on patient characteristics, utilization, and outcomes of new medicines in real world settings, to external control arms in the situation of a rare disease where randomized clinical trials are not suitable.

In this Theater presentation, representatives from Ontada will present various uses cases of RWE in oncology decision making, including longitudinal cohorts (which can provide insights about real world use and outcomes) and considerations and challenges associated with external control arms. We will also highlight the importance of the technology and how technology can link different data sources through interoperability as well as allow access to source data for audit purposes.

Seating is limited.

Sponsor: Ontada