External control · high severity
The control is contemporaneous and reflects current care
A control treated before the current standard of care is a comparison against a different standard, not against what patients face now. The reviewer cares about the care available today.
The check
Does the outline show the external control patients were treated in the same period and under the current standard of care?
What the outline has to carry
- a contemporaneous period
- current standard of care
A check is met only when every element above is present. One element on its own is a partly evidenced check, not a pass.
What resolves it
State the calendar period for the control, the treatments in use in that period, and how the period was chosen. If the control predates a practice change, say so and show the analysis by period.
The source sentence
Contemporaneous data is necessary to make sure you're not comparing against an outdated standard of care.FDA Watch, 32:20 to 33:15
The quotation is short and is used to show the sentence the rule is read from. The rule itself is our statement, not the speaker's words.
The legal basis
The held frameworks that bear on this check, with the control each one contributes. The link opens the framework page so the reader can check the source.
Data management and external data
A data management plan covers external data, including real-world data, its quality, its traceability and its coordination with the analysis.
International · Read the framework
Try it on your outline. The free check applies this rule and quotes the line it read.