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