External control · high severity
The external control uses the trial's eligibility criteria
A control drawn from a looser population is not a comparison. The external patients have to satisfy the same rules that decided who entered the trial, or the difference between arms includes the difference in who was selected.
The check
Does the outline say the external control patients were selected by the trial's own eligibility rules?
What the outline has to carry
- an external control
- eligibility
- matching
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
Reproduce the trial eligibility criteria in the control selection, state how each criterion was operationalised in the external data, and list the criteria that could not be applied and what that does to the comparison.
The source sentence
A credible external control needs to match the trial eligibility criteria and endpoint definitions.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.
Protocol and study reporting
The protocol states the objectives, design, population, endpoints, analysis and reporting before the study begins.
International · Read the framework
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.