Developing Real-world Evidence-Ready Datasets: Time for Clinician Engagement

Area of Science:

• Healthcare Data Science
• Clinical Informatics
• Real-World Evidence

Background:

• Real-world data (RWD) applications are expanding in healthcare, driven by legislative support for real-world evidence (RWE) in drug approvals.
• Clinical notes are vital for RWD applications, especially in complex or poorly understood conditions.
• RWD supports learning health systems and pragmatic clinical trials.

Purpose of the Study:

• To discuss current challenges in applying point-of-care RWD.
• To propose a framework for clinician engagement in RWD collection.
• To highlight the importance of consistent terminology for clinically meaningful RWD.

Main Methods:

• Review of current issues in RWD application.
• Framework development for clinician engagement in RWD collection.
• Emphasis on consistent terminology for reliable data capture.

Main Results:

• RWD complements traditional research by assessing generalizability and generating hypotheses.
• Effective clinician involvement is necessary for advancing RWD applications.
• Reliable RWD capture requires consistent terminology.

Conclusions:

• Clinician engagement is key to unlocking the full potential of RWD.
• Standardized data collection practices are crucial for generating high-quality RWD.
• RWD offers significant value for scientific discovery and healthcare improvement.