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ForumsClinical Trials & ResearchPhase 3 trial enrollment guide — my results so far

Phase 3 trial enrollment guide — my results so far

josh_phd_bmore Mon, Feb 23, 2026 at 12:22 PM 21 replies 1,019 viewsPage 1 of 5
josh_phd_bmore
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Feb 23, 2026 at 12:22 PM#1

My own curve sits about four points below the published mean and I spent two months assuming that meant something was wrong with me or with my material.

A quick sanity check on any figure quoted here: is it mean or median, is it intention-to-treat or completers, and what was the comparator. Three questions, and they resolve most disagreements in these threads.

The bit I cannot resolve on my own is how to read a result like this without either dismissing it or over-reading it, since the summaries all read like press releases.

Numbers rather than impressions, if you have them.

22 0NurseKim_ATL, paul_denver, TinaHashiRN and 19 others
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Dr.GutHealth
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Feb 23, 2026 at 1:19 PM#2

This one has a reasonably settled answer, so here it is. Read four things before the headline number. The population, because trial populations are selected and supported in ways that real cohorts are not. The comparator, because "better than placebo" and "better than the current standard" are different claims and get reported identically. The primary endpoint as pre-registered, because a secondary endpoint promoted after the fact is a hypothesis rather than a finding. And the completion rate, because a large effect in the half of participants who finished is a different result from a large effect in everybody enrolled.

23 1tyler_CSCS, VanRx_Mike, steve_okc and 20 others
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rachel_ABQ
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Feb 23, 2026 at 2:16 PM#3
Dr.GutHealth said:
Read four things before the headline number.
Dr.GutHealth said:
...regarding the trial evidence...

I think this is an underappreciated point. To expand on it with some data:

A recent meta-analysis of 12 RCTs (n=8,400) found that the trial evidence was associated with a significant effect size across diverse patient populations[1].

The NNT was 8, which is comparable to statins for secondary prevention. That's a strong clinical argument for this approach.

Last edited: Feb 23, 2026 at 7:16 PM
24 2AmyNC_wife, SkepticalSean, Dr.CardioMD and 21 others
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DadBodDave
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Feb 23, 2026 at 3:13 PM#4
josh_phd_bmore said:
My own curve sits about four points below the published mean and I spent two months assuming that meant something was wrong with me or with my…

Same position here, arrived at the long way round. Relative and absolute effects need reading together. A 20% relative reduction on a high baseline risk is a large absolute benefit; the same relative figure on a low baseline risk is a small one, and press summaries almost always quote the relative number because it is bigger.

Last edited: Feb 23, 2026 at 6:13 PM
25 3Dr.GastroMayo, JakeBK_lifts, DerekSJ_a1c and 22 others
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EndoResFellow
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Feb 23, 2026 at 8:39 PM#5

Clinical perspective, offered as context rather than as advice.

Forest plot interpretation for the the trial evidence meta-analysis: when reading the pooled estimate, pay attention to:

  1. Point estimate (HR/RR/OR) — center of the diamond
  2. Confidence interval width — precision of the estimate
  3. I² statistic — heterogeneity across studies
  4. Individual study weights — are results driven by one large trial?
  5. Prediction interval — range of plausible true effects in future settings

The the trial evidence meta-analysis shows a pooled RR of 0.78 (95% CI 0.66-0.83), I²=51%. This is a robust and consistent effect.

Last edited: Feb 23, 2026 at 10:39 PM
26 4Dr.ObesityLA, NurseKim_ATL, paul_denver and 23 others
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