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ForumsClinical Trials & ResearchCan we talk about how SLOW the FDA is

Can we talk about how SLOW the FDA is

KarenAZ_mom Mon, Apr 20, 2026 at 10:27 AM 38 replies 1,036 viewsPage 1 of 8
KarenAZ_mom
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Apr 20, 2026 at 10:27 AM#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 would genuinely help is knowing how to read a result like this without either dismissing it or over-reading it, since the summaries all read like press releases.

If the honest answer is that nobody knows, that is a useful answer and I would rather have it.

17 20anna.melb_AU, mark_tokyo, hans_munich and 14 others
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DataDave
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Apr 20, 2026 at 10:42 AM#2

Answering the narrow version, because the broad one does not have a single answer. 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.

Last edited: Apr 20, 2026 at 11:42 AM
18 21mike_nyc, VendorMark, COA_Karl and 15 others
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tampaLisa73
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Apr 20, 2026 at 10:57 AM#3
DataDave said:
Read four things before the headline number.

Bayesian meta-analysis perspective on the trial evidence: traditional frequentist meta-analyses report point estimates and confidence intervals. Bayesian approaches provide probability distributions that are more intuitive for clinical decision-making.

For example: "There is a 98.5% probability that semaglutide 2.4mg produces >10% weight loss vs placebo" is more actionable than "RR 3.4, 95% CI 2.8-4.1, p<0.001."

The the trial evidence evidence is strong under both frameworks, but Bayesian analysis better communicates the degree of certainty for individual patient counseling.

Last edited: Apr 20, 2026 at 11:57 AM
19 22sarah_nash92, FitDadDave, RunnerRach and 16 others
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Dr.PathRoch
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Apr 20, 2026 at 11:12 AM#4
KarenAZ_mom 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…

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: Apr 20, 2026 at 5:12 PM
20 23SaraMom3, Dr.MetabolicMD, RetaRick_CA and 17 others
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sarah_TO
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Apr 20, 2026 at 12:35 PM#5

Adding the clinical framing, because it changes how the question reads.

KarenAZ_mom said:
...regarding the trial evidence...

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

A recent meta-analysis of 22 RCTs (n=18,900) found that the trial evidence was associated with a consistent effect size across diverse patient populations[1].

The NNT was 20, which is comparable to statins for secondary prevention. That's a strong clinical argument for this approach.

Last edited: Apr 20, 2026 at 4:35 PM
21 24DanielChem_CHI, marco_milano, pam_columbus and 18 others
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