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Evidence · Trials

Interim analyses and stopping rules — does this still hold?

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Solved by k.marchand in post #3
Adding the measurement that the opening post says would settle it. Absolute and relative effects answer different questions. Write down the event rate in each arm and the difference between them; everything quotable is derived from those two numbers.

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JD
j.delacroixTL3Regular21 Jun 2025#1

Interim analyses and stopping rules — does this still hold? — that is the question, and I have not found it answered plainly anywhere I have looked.

Interim analyses and stopping rules, from the point of view of someone who has read the documentation and is still stuck.

Saying which parts I have understood so that nobody wastes time re-explaining them, and where exactly the understanding stops.

33 likes 13mo
MH
m.haddadTL2Regular22 Jun 2025#2

I had written a reply contradicting the opening post and deleted it. Here is what survived.

Where I would push back on the Interim analyses and stopping rules consensus is the confidence, not the direction. The direction looks right. The confidence is borrowed.

0 likes 13mo
KM
k.marchandTL2 Solution23 Jun 2025#3

Adding the measurement that the opening post says would settle it.

Absolute and relative effects answer different questions. Write down the event rate in each arm and the difference between them; everything quotable is derived from those two numbers.

8 likes 13mo
FT
fr.translation_moTL2Translator · FR23 Jun 2025#4

Interim analyses and stopping rules looks different depending on whether you are reading the primary literature or the summaries of it, and the difference is not in our favour.

7 likes 13mo
HL
h.lindqvistTL224 Jun 2025 · edited#5

Post #4 is the version of this I will quote in future. One addition.

On Interim analyses and stopping rules the community has more anecdote than the confidence in this thread implies, and I include my own contribution in that.

25 likes 13mo
AD
appeals_deskTL3Regular24 Jun 2025#6
k.marchand, post #3: Adding the measurement that the opening post says would settle it. Absolute and relative effects answer different questions. Write down the event rate in each arm and the difference between them; everything quotable is derived from those two numbers. Go to post

Grateful for the specificity. Vague answers to this question are what sent me looking.

0 likes in reply to #3 13mo
SA
s.adebayoTL225 Jun 2025#7

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.

Two people can read the same figure differently here and both be reasonable.

4 likes 13mo
WP
weekly_pinTL2Regular25 Jun 2025#8

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.

Noting that the question and the thing people usually mean by it are different.

11 likes 13mo
FP
f.piresTL226 Jun 2025#9

Distinguishing three things in the Interim analyses and stopping rules discussion that keep getting used interchangeably: the observation, the proposed mechanism, and the recommendation that gets attached to both.

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GD
glossary_deskTL3Regular26 Jun 2025#10

Checked the Interim analyses and stopping rules claim against the primary source this morning. It survives, with a narrower scope than the version quoted here. Posting the narrower scope.

19 likes 13mo
JV
j.vogelTL227 Jun 2025#11
RI
retention_indexTL2Analytical chemist27 Jun 2025#12
fr.translation_mo, post #4: Interim analyses and stopping rules looks different depending on whether you are reading the primary literature or the summaries of it, and the difference is not in our favour. Go to post

Post #9 is right about the mechanism and I think understates the practical bit.

What I can speak to on Interim analyses and stopping rules is narrow, so I will keep it narrow rather than generalising from it. Beyond that boundary I do not know.

10 likes in reply to #4 13mo
MA
m.adeyemiTL227 Jun 2025#13

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.

I am aware this is the third time this month I have made this point.

3 likes 13mo
GV
g.verhoevenTL228 Jun 2025#14

The most useful reply I ever got about Interim analyses and stopping rules was a request to state my units. It sounds like pedantry and it has saved me twice.

0 likes 13mo
Z
ZieglerTL3Regular28 Jun 2025#15
glossary_desk, post #10: Checked the Interim analyses and stopping rules claim against the primary source this morning. It survives, with a narrower scope than the version quoted here. Posting the narrower scope. Go to post

Second this, and I would have said it less carefully.

30 likes in reply to #10 13mo
MD
m.dumitruTL229 Jun 2025#16
s.adebayo, post #7: 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. Two people can read the same figure differently here and both be reasonable. Go to post

Interim analyses and stopping rules is a question about a distribution, not about a value, and treating it as a value is what produces the confident wrong answers.

15 likes in reply to #7 13mo
DW
diluent_watchTL2Member29 Jun 2025#17

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.

Adding the caveat now so it does not have to be extracted later.

6 likes 13mo
ZV
z.vogelTL229 Jun 2025 · edited#18

Picking up post #17: that is the part I would want checked first.

One more thing on Interim analyses and stopping rules that took me far too long to see: the two figures people quote are not measuring the same quantity. Once you notice that, the apparent contradiction disappears.

1 like 13mo
GL
glossary_lineTL1Member30 Jun 2025#19

Subgroup analyses are hypothesis-generating unless pre-specified and adequately powered, and almost none are the second. The interaction test matters more than the subgroup point estimate.

The variance between people here is larger than the effect being discussed.

11 likes 13mo
CV
ca.vermeulenTL230 Jun 2025#20

Absolute and relative effects answer different questions. Write down the event rate in each arm and the difference between them; everything quotable is derived from those two numbers.

Speaking for myself and not for anyone else who has posted here.

3 likes 13mo
MB
ma.balogunTL230 Jun 2025#21

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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D
DOdendaalTL3Regular1 Jul 2025#22

I had read the opposite somewhere and cannot now find where, which tells me something.

1 like 13mo
RI
r.ilungaTL21 Jul 2025#23
ca.vermeulen, post #20: Absolute and relative effects answer different questions. Write down the event rate in each arm and the difference between them; everything quotable is derived from those two numbers. Speaking for myself and not for anyone else who has posted here. Go to post

A note on scope: what I am saying about Interim analyses and stopping rules applies to the case in the first post and I would not extend it further without checking.

10 likes in reply to #20 13mo
ED
e.dalgleishTL3Regular1 Jul 2025#24

Answering the question post #20 raises rather than the one it answers.

Interim analyses and stopping rules has been discussed here with more heat than it deserves, mostly because two definitions have been in play the whole time.

23 likes 13mo
DN
d.nilsenTL22 Jul 2025#25

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.

This is the sort of thing the wiki should carry and currently does not.

0 likes 13mo
SC
septum_checkTL1Member2 Jul 2025#26

What I would tell a new member reading about Interim analyses and stopping rules for the first time: the confident posts are not the reliable ones, and the reliable ones are longer.

3 likes 13mo
CM
c.marchettiTL22 Jul 2025#27
septum_check, post #26: What I would tell a new member reading about Interim analyses and stopping rules for the first time: the confident posts are not the reliable ones, and the reliable ones are longer. Go to post

Narrowing post #26, because the general version has more than one answer.

Interim analyses and stopping rules would be much easier to settle if anyone reported the denominator. Almost nobody reports the denominator.

15 likes in reply to #26 13mo
M
MJayawardenaTL3Regular3 Jul 2025#28
appeals_desk, post #6: Grateful for the specificity. Vague answers to this question are what sent me looking. Go to post

Everything in post #24 holds. The case it does not cover is the one I have.

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.

31 likes in reply to #6 13mo
NS
n.szaboTL23 Jul 2025#29

This follows post #26 rather than contradicting it.

Trying to state the Interim analyses and stopping rules position in a way that someone who disagrees would recognise as fair, because I do not think the version in this thread passes that test.

1 like 13mo
ID
integrator_draftTL3Regular3 Jul 2025#30

Worth separating two things that post #28 runs together.

Interim analyses and stopping rules sits at the boundary between what this community can usefully discuss and what it cannot, and I think it falls on the discussable side, narrowly.

6 likes 13mo