November 6: Developing Decision-Grade Real-World Evidence - In Person at ISPOR Europe 2022
In this course, participants will be guided through a hands-on analysis of real-world data 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 ChromeTM installed.
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.
Brigham & Women’s Hospital
Harvard Medical School and Harvard School of Public Health
Boston, MA, USA
Dorothee B. Bartels, PhD, MSc
Head of Global RWE and Digital Sciences
UCB Biosciences GmbH
Monheim, Germany
November 6, 2022
Back to all short courses
Developing Decision-Grade Real-World Evidence
LEVEL: Intermediate
TRACK: Real World Data & Information Systems
LENGTH: 4 Hours | Course runs 1 day
This short course will be offered in-person at the ISPOR Europe 2022 conference. Separate registration is required. Visit the ISPOR Europe 2022 website to register and learn more.
DESCRIPTION
In this course, participants will be guided through a hands-on analysis of real-world data 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 ChromeTM installed.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.
FACULTY MEMBERS
Sebastian Schneeweiss, MD, ScDBrigham & Women’s Hospital
Harvard Medical School and Harvard School of Public Health
Boston, MA, USA
Dorothee B. Bartels, PhD, MSc
Head of Global RWE and Digital Sciences
UCB Biosciences GmbH
Monheim, Germany
Basic Schedule:
4 Hours | Course runs 1 Day