Observational studies to emulate randomized trials: Some real‐world barriers
Samy Suissa
Abstract:The randomized controlled trial (RCT) forms the basis for drug approval by regulatory agencies. Observational studies using existing data from healthcare databases now also provide real‐world evidence (RWE) in regulatory decision‐making. Several initiatives are assessing the value of RWE by conducting observational studies that emulate published RCTs. While many RCTs are straightforward to emulate, others are challenging. We describe three RCT design aspects that pose challenges for observational studies. Firs… Show more
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