Developing Decision-Grade Real-World Evidence
Author(s)
Faculty: Sebastian Schneeweiss, MD, ScD, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA Jeremy Rassen, ScD, Aetion, Inc., New York, NY, USA; Shirley Wang, PhD, Brigham & Women's Hospital, Harvard Medical School, Boston, MA, USA
In this course, participants will be introduced to the principles of what makes real-world evidence (RWE) decision-grade, including an extended example. In the first half of the course, will review the most recent RWE frameworks and guidelines, and examine case studies in which RWE was used in regulatory and HTA approval. The second half of the course is an extended example in which participants will examine a study that could support an indication expansion, and interactively discuss how choices made in the design and implementation may affect the meaning and interpretability of results.
PREREQUISITE: Students are expected to be familiar with relevant concepts and methodologies for analyzing real-world data.
Conference/Value in Health Info
Code
001
Topic
Real World Data & Information Systems