Real World Data

The Real World Data initiative aims to collaborate with global regulatory agencies to develop a framework for RWD that defines tools, methodologies, use cases, and appropriate levels of evidence to support regulatory decision-making.

Key resources


Supplementing or replacing clinical trial data with Real World Data (RWD) to inform regulatory decisions is a transformative, ambitious goal that has the potential to substantially contribute to the totality of evidence regarding the benefits and risks of drug products. Leveraging RWD can benefit both patients and researchers.


  • Enhanced evidence generation through RWD potentially leading to improved patient outcomes
  • Enhanced credibility and increased awareness of appropriate use of RWD
  • Increased confidence in acceptance of RWD for regulatory decision making

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