Topic summary
Non-inferiority margins: how they are chosen and how they are abused
This is a generated summary. It shows the 7 most-liked posts from a topic of 47, in their original order, with the accepted answer included where one exists. It is a reading aid and it will miss nuance — the full topic is the record.
l.dziedzic, post #7: Taking post #4 at face value and following it one step further. I would keep non-inferiority margins and the decision it usually gets used for separate in this thread. They are related and they are not the same question, and merging them is why the last one went badly. Go to post
Following, with nothing to contribute beyond having asked the same thing elsewhere.
Risk of bias: structured appraisal of internal validity. Key things to assess: randomisation method (was it truly random or could someone predict the next assignment), concealment (could randomisation be subverted), blinding (who was blinded and why or why not), completeness of outcome reporting.
23 likes 6mo
d.oyelaran, post #4: Post #2 put the caveat in the right place and I want to underline it. Absolute numbers, not just relative: a 30% relative reduction tells you the ratio but not the practical magnitude. The event rate in each arm and the difference between them tells you how many people benefit. It is worth checking rather than assuming, which costs… Go to post
Post #38 describes the usual case. This is about the unusual one.
Non-inferiority margins are chosen, and the choice is an argument rather than a fact. A wide margin can make a worse treatment look acceptable.
Genuinely open to being wrong about this one.
Read the full topic (47 posts)
This topic was referenced in
- Interim analyses and stopping rules — does this still hold?Evidence › Trials · 34 replies
- Revisiting: Primary endpoint hierarchies and why order mattersEvidence › Trials · 25 replies
Promoted into the documentation commons. The content of this topic is maintained at STEP 8 — trial digest, with named maintainers and a review date. The promotion was discussed in doc review. Corrections are best raised against the document, which is the version that gets kept current.
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