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ForumsClinical Trials & ResearchCan we talk about how SLOW the FDA is — my results so far

Can we talk about how SLOW the FDA is — my results so far

NurseAsh_DET Tue, Nov 18, 2025 at 7:47 PM 43 replies 1,294 viewsPage 1 of 9
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NurseAsh_DET
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Sep 2024
Detroit, MI
Nov 18, 2025 at 7:47 PM#1

I keep finding that the number in the press summary and the number in the paper are not the same number, and the difference is always in the same direction.

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.

What I am trying to establish is how to read a result like this without either dismissing it or over-reading it, since the summaries all read like press releases.

Practical detail welcome, however dull — the duller the better.

31 9FDA_TrackerJim, ricardo_MIA, BrianDallas92 and 28 others
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labquiet_amy
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Cambridge, MA
Nov 18, 2025 at 8:17 PM#2

Taking the question as asked, rather than the general version of it. 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.

32 10HPLC_Greg, LibrarianMeg, bri_stats and 29 others
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newstart_MO
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Springfield, MO
Nov 18, 2025 at 8:48 PM#3
labquiet_amy said:
Read four things before the headline number.

Propensity score matching studies and the trial evidence: when RCTs aren't available for a specific question, propensity score-matched observational studies can provide useful evidence.

A recent PSM study of 25,000 GLP-1 users vs matched controls showed reduced stroke risk (HR 0.82) over 5 years of follow-up[1].

These results complement the RCT data and suggest the benefits translate to real-world populations.

References:
[1] Registry-based cohort study, pre-print 2024.
33 11HPLC_Greg, LibrarianMeg, bri_stats and 30 others
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hannah_MT
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Nov 18, 2025 at 9:18 PM#4
NurseAsh_DET said:
I keep finding that the number in the press summary and the number in the paper are not the same number, and the difference is always in the same…

Can confirm the pattern NurseAsh_DET describes. 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: Nov 19, 2025 at 12:18 AM
34 12PurityPaulOR, MaxMetOK, MounjBrad and 31 others
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Dr.GutHealth
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Minnesota
Nov 19, 2025 at 12:09 AM#5

From the other side of the consultation, briefly.

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 0.80 (95% CI 0.69-0.90), I²=38%. This is a robust and consistent effect.

Last edited: Nov 19, 2025 at 5:09 AM
35 13MikeKY_noInsulin, Dr.RaviCardio, jennifer_SEA and 32 others
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