External control · high severity
The single-arm design is justified and the external control is fixed before unblinding
A control chosen after the trial result is a control chosen to produce it. The design has to be justified on clinical and ethical grounds, and the comparator fixed before anyone sees the arm.
The check
Does the outline justify why a single-arm design is appropriate, and state that the external control was fixed before the trial result was known?
What the outline has to carry
- a single-arm design
- a justification
- fixed before the result
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 clinical reason a randomised control is not feasible or not appropriate, and the date the external control and its analysis were locked. Name who locked it and what would have happened if the control had looked different.
The source sentence
Where a single-arm trial is compared against similar patients drawn from real-world sources. And this is where the bar is highest.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
Scope and principles
The standard sets the ethical and scientific quality requirements for designing, conducting, recording and reporting studies, applied in proportion to risk.
International · Read the framework
Try it on your outline. The free check applies this rule and quotes the line it read.