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. 2022 Feb 6;22:39. doi: 10.1186/s12874-022-01525-9

Table 5.

Approach to multiplicity due to interim analyses

a) Review: approach taken to multiplicity
Formal adjustment Hierarchical testing Other approach None
Interim analyses 26/41a (63%) 0/41 (0%) 2/41b (5%) 13/41c (32%)
b) Survey: responses to posed scenarios
Always Sometimes Never Unsure
Would you adjust for multiplicity if interim analysis(es) were pre-specified in the study protocol? 8/27 (30%) 12/27 (44%) 3/27 (11%) 4/27 (15%)

Notes: a Eight trials used the Haybittle-Peto procedure, eight used O’Brien-Fleming, seven partitioned the significance level between final and interim analyses (with no further details given), one used Pocock, one used Lan DeMets and one did not give details.

bOne trial used a group sequential design and one used a conditional rejection probability approach.

cOf these, three trials stated a pre-specified significance level for stopping the trial.