Robustness · medium severity
Subgroup analyses are pre-specified, with a multiplicity position
A subgroup found after the data is seen is a hypothesis, not a finding. Pre-specifying the groups and saying how the error rate is handled keeps the subgroup from becoming the headline.
The check
Are the subgroups named in advance, and does the outline say how many comparisons it is making?
What the outline has to carry
- subgroups
- pre-specified
- a multiplicity position
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
List the pre-specified subgroups, say which are confirmatory and which are exploratory, and state the multiplicity method or say plainly that the subgroup analyses are descriptive.
The source sentence
Subgroup analyses, different ways to look at the data.FDA Watch, 30:36 to 31:28
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.