Has anyone dealt with trial endpoint primer?

BariatricNurseD said:

Relative and absolute effects need reading together.

BariatricNurseD has the substance of this right. The condition it depends on is worth stating. The gap between trial results and real-world results is consistent and it is not fraud. Trial participants get titration by protocol, scheduled contact, free drug and dietetic support; removing that infrastructure costs a few percentage points every time it has been measured. When your own curve sits below the published mean, that is the likeliest explanation before anything about you or your material.

BariatricNurseD said:

Relative and absolute effects need reading together.

Pushing back on BariatricNurseD 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.

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.

julia.endo said:

The gap between trial results and real-world results is consistent and it is not fraud.

Mine went the same way, slower.