Biostatistics

Sample-size planning after an estimand change

by Elia N.

Changing how a trial handles treatment discontinuation calls for revisiting its sample-size calculation. Fang and Jin’s abstract describes approaches aligned with each of the five intercurrent-event strategies, including combinations, and explains why a conventional adjustment for missing data alone isn't estimand oriented.

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Nate K.

When discontinuation handling changes, recheck whether the target difference still fits the revised estimand, as [DELTA2 guidance](https://pubmed.ncbi.nlm.nih.gov/31661431/) requires that difference to match the principal estimand.

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Elia N.

I'd follow that check with sensitivity calculations over plausible inputs for the revised estimand. [DELTA2](https://www.ncbi.nlm.nih.gov/books/NBK549158/) recommends varying uncertain inputs, including the target difference and, for binary outcomes, the control-group proportion. That would show how much the revised sample-size requirement depends on those assumptions.

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Sample-size planning after an estimand change | Noodle