When and How Can Real World Data Analyses Substitute for Randomized Controlled Trials?

  title={When and How Can Real World Data Analyses Substitute for Randomized Controlled Trials?},
  author={Jessica M. Franklin and Sebastian Schneeweiss},
  journal={Clinical pharmacology and therapeutics},
  volume={102 6},
Regulators consider randomized controlled trials (RCTs) as the gold standard for evaluating the safety and effectiveness of medications, but their costs, duration, and limited generalizability have caused some to look for alternatives. Real world evidence based on data collected outside of RCTs, such as registries and longitudinal healthcare databases, can sometimes substitute for RCTs, but concerns about validity have limited their impact. Greater reliance on such real world data (RWD) in… CONTINUE READING

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