31 August 2021
Developing Decision-Grade Real-World Evidence
LEVEL: Intermediate
TRACK: Real World Data & Information Systems
LENGTH: 4 Hours | Course runs 1 day
PREREQUISITE: Students are expected to be familiar with relevant concepts and methodologies for analyzing real-world data, but this course does not require specific programming skills.
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9:00AM-1:30PM EDT
1:00PM-5:30PM UTC/GMT
3:00PM-7:30PM CEST
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DESCRIPTION
In this course, participants will be guided through a hands-on analysis of real-world data (RWD) to develop decision-grade real-world evidence (RWE) that could be used to support an indication expansion. The first section of the course focuses on what makes RWE “decision-grade.” We will review the most recent RWE frameworks and guidelines set by regulatory agencies and professional organizations, and we will examine case studies in which these guidelines were used in regulatory and HTA approval. The second half of the course is an active workshop where participants will use principles from the first half of the course to execute a decision-grade RWE study. Participants will be guided step-by-step in using a software platform that will enable them to work within a longitudinal US insurance claims database with anonymized patients. After the study has been executed, we will discuss how these results could be communicated to decision makers. Participants should come with a laptop with Google Chrome installed.
FACULTY MEMBERS
Sebastian Schneeweiss, MD, ScD
Professor of Medicine and Epidemiology
Harvard Medical School and Brigham & Women’s Hospital
Boston, MA, USA
Jeremy Rassen, ScD
President & Chief Science Officer
Aetion, Inc.
New York, NY, USA
Ashley Jaksa, MPH
VP Science/Sr. Scientist
Aetion, Inc.
Boston, MA, USA
Basic Schedule:
Class Time: 2 hours of content | 30 minute break | 2 hours of content