Abstract

Trial Emulation and Real-World Evidence

Highlights

  • There are various reasons why the results of randomized clinical trials (RCTs) may not apply directly to daily clinical practice

  • The quality of electronic health records data tends to be inferior compared with those collected in RCTs, there are examples in which they appear to be on par.[2]

  • Because this information becomes available during the study follow-up and is not yet available at study entry, this introduces the risk of immortal time bias; participants have to survive until a certain time to classify as having received a certain exposure level

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Summary

Introduction

There are various reasons why the results of RCTs may not apply directly to daily clinical practice. Observational studies, in contrast, are based on what is called real-world data, such as those from electronic health records, and often better represent daily practice. They used observational data to mimic an RCT as much as possible, a technique called target trial emulation.[4]

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