Developing Study Endpoints in Real-World Settings

To advance the use of real-world data (RWD) and real-world evidence (RWE) for regulatory decision-making, robust and relevant endpoints that can address a research question about a medical product’s effectiveness in the real-world setting are needed. While there is extensive literature on developing and validating endpoints in the clinical trial setting, uncertainty remains in how to translate relevant principles to the real-world setting. 

Duke-Margolis Center for Health Policy is hosting a public webinar to showcase the Real-World Evidence Collaborative’s recent white paper that details a roadmap for developing real-world endpoints. A panel of experts will discuss key points from the white paper and offer insights about the future of real-world endpoint development. Key topic areas include:

• Standardizing terminology across stakeholder groups
• Utilizing a roadmap for selecting the concept of interest, outcome, and endpoint components
• Applying existing frameworks from the clinical trial setting to real-world endpoint development
• Selecting and validating the measurement tool
• Identifying opportunities to advance the use and acceptability of real-world endpoints for regulatory decision-making.