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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.

Rationale

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.

Benefits

  • 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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