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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
MikeFit_NJ
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Nov 19, 2025 at 3:00 AM#6
labquiet_amy said:
Read four things before the headline number.

Pushing back on labquiet_amy here. 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.

Correct me if the detail matters more than I have assumed.

36 14LeilaHI, marcus_mpls, DeniseRN_TPA and 33 others
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Dr.PathRoch
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Nov 19, 2025 at 5:51 AM#7
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…
NurseAsh_DET said:
...regarding the trial evidence...

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

A recent meta-analysis of 15 RCTs (n=12,300) found that the trial evidence was associated with a clinically meaningful effect size across diverse patient populations[1].

The NNT was 12, which is comparable to statins for secondary prevention. That's a strong clinical argument for this approach.

37 15InsuranceTom, WendyG_ATL, SaraMom3 and 34 others
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hyun_seoul
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Seoul, KR
Nov 19, 2025 at 8:42 AM#8
MikeFit_NJ said:
I would add the less popular caveat: these trial populations under-represented several groups, older adults and the highest BMI categories among them.

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.

38 16MASHdoc_SA, GenomicsKate, Dr.ObesityMed and 35 others
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andrew_nyc
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Nov 19, 2025 at 11:33 AM#9

One thing that is still open after newstart_MO’s answer:

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

39 17julia.endo, JessicaM_2024, TomFromTexas and 36 others
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NurseAsh_DET
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Nov 20, 2025 at 1:15 AM#10

Closing the loop on my own question.

Follow-up: I read the paper rather than the summary and the qualifier I was missing was in the second paragraph of the results.

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