Answer
What is an external control arm in a real-world evidence study?
An external control arm is a comparison group drawn from outside the trial, usually from real-world data, used when a single-arm trial is the design. It is judged on whether it is the same patient, the same endpoint and the same standard of care, and whether the analysis addresses confounding in a way fixed before the comparison is run. The recorded source is specific: a credible external contro
An external control arm is a comparison group drawn from outside the trial, usually from real-world data, used when a single-arm trial is the design. It is judged on whether it is the same patient, the same endpoint and the same standard of care, and whether the analysis addresses confounding in a way fixed before the comparison is run.
The recorded source is specific: a credible external control needs to match the trial eligibility criteria and endpoint definitions, address sources of bias such as confounding, and use contemporaneous data so the comparison is not against an outdated standard of care. The episode also notes that the standard of care at the collecting sites should be comparable to the market the sponsor is filing in.
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