Real-World Evidence in Healthcare Decision-Making

This document outlines the role of real-world evidence (RWE) in healthcare decisions. RWE consists of data from everyday healthcare settings regarding the use, safety, and efficacy of medical devices, technologies, and medications. It encompasses non-clinical trial data on individual health and healthcare delivery.

Key Points:

• Definition: RWE is derived from real-world data (RWD) and must be relevant and reliable to inform decisions.
• Complementary Evidence: RWE supports traditional randomized controlled trials by providing additional insights on the benefits and risks of medical products in diverse patient populations and settings.
• Applications: It can be used to:
  • Evaluate long-term health outcomes.
  • Analyze trends in care utilization.
  • Inform drug approval processes by addressing gaps in clinical trial evidence.
• Limitations: While RWE offers valuable insights, it cannot establish cause and effect due to potential biases and variability in data quality based on measurement and reporting methods.

Region: Canada

Source: https://www.cadth.ca/real-world-evidence-primer