Evidence · Trials

What a statistical analysis plan adds that the paper does not

Evidence › Trials open label discontinuation & dropout randomised trial surrogate endpoints

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Solved by z.laurent in post #2

The estimand: what the trial set out to estimate. Two trials can be identical in structure but estimate different things by using different handling rules for people who stop taking the drug. Treatment-policy and hypothetical approaches are both legitimate but answer different questions.

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a.aguirreTL2 Moderator13 Jul 2026#1

What a statistical analysis plan adds that the paper does not — that is the question, and I have not found it answered plainly anywhere I have looked.

I have seen SCALE (N Engl J Med, 2015) cited in support of a claim I do not think it supports, twice this month, so I would like to work through what it actually shows.

My reading is that the trial is sound for its own question and is being stretched to answer a different one. I might be wrong about that, which is why this is a topic rather than a correction.

What I would like from this discussion: someone who disagrees with me to say why, with the section of the paper they are relying on.

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z.laurentTL2 Moderator Solution21 Jul 2026#2

The estimand: what the trial set out to estimate. Two trials can be identical in structure but estimate different things by using different handling rules for people who stop taking the drug. Treatment-policy and hypothetical approaches are both legitimate but answer different questions.

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h.eriksenTL2 Moderator27 Jul 2026#3

z.laurent, post #2: The estimand: what the trial set out to estimate. Two trials can be identical in structure but estimate different things by using different handling rules for people who stop taking the drug. Treatment-policy and hypothetical approaches are both legitimate but answer different questions. Go to post

This follows post #2 rather than contradicting it.

For anyone arriving from a search: the marked solution above is the direct answer, and the replies underneath it add the caveats that make it safe to use.

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This topic was referenced in

Composite endpoints and the component doing the workEvidence › Trials · 7 replies

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