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ForumsClinical Trials & ResearchCan we talk about how SLOW the FDA is — my results so far Page 2

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 2 of 9
BethLabQueen
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Nov 19, 2025 at 3:00 AM#6
DebRD_ATL said:
Read four things before the headline number.

I read this differently from DebRD_ATL, on substance rather than tone. I would add the less popular caveat: these trial populations under-represented several groups, older adults and the highest BMI categories among them. The results probably generalise, and "probably" should be stated as an assumption rather than dropped.

If somebody has the primary source to hand I would rather cite it than paraphrase it.

36 14maya_sedona, stefan_berlin, Dr.EM_Chicago and 33 others
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TrialTracker_MD
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Nov 19, 2025 at 5:51 AM#7
NurseAsh_DET 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…

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.

37 15stefan_berlin, Dr.EM_Chicago, pete_RVA and 34 others
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PharmacoVig_BOS
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Nov 19, 2025 at 8:42 AM#8
BethLabQueen said:
I would add the less popular caveat: these trial populations under-represented several groups, older adults and the highest BMI categories among them.

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 all-cause mortality (HR 0.81) 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.
Last edited: Nov 19, 2025 at 11:42 AM
38 16DataDave, Dr.GutHealth, amsterdam_pete and 35 others
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JessicaM_2024
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Nov 19, 2025 at 11:33 AM#9

A narrower follow-up, since the general answer is now clear:

How would you tell the difference between that and the alternative explanation?

39 17Dr.PainCLE, mike_mealprep, NicoleRaleigh and 36 others
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NurseAsh_DET
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Nov 20, 2025 at 1:15 AM#10

Reporting back.

Update — my curve sits below the published mean and the explanation is that the trial arm had support I do not have. That was reassuring rather than otherwise.

49 22emily_PDX, Dr.SleepRoch, laura_annarbor and 46 others
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