Real-World Evidence in Clinical Trials

Clinical trials are a cornerstone of medical research, providing essential data to determine the safety and efficacy of new treatments and interventions. Traditionally, these trials have been conducted under controlled conditions with carefully selected participants. However, the landscape of evidence generation is evolving, and there is an increasing recognition of the importance of incorporating real-world evidence (RWE) into the clinical trial process.


  • Definition and Scope of Real-World Evidence (RWE)
  • Advantages and Limitations of RWE
  • Use of RWE in Drug Development and Approval
  • RWE in Rare Diseases and Orphan Drugs

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