STEP 2 misses on a secondary endpoint the coverage has not mentioned
A design note rather than a result: what the comparator was, and what that permits you to conclude.
Clinical Trials
The trial programmes — STEP, SURMOUNT, SURPASS, SELECT, FLOW, TRIUMPH and the outcome studies that followed — read as designs rather than headlines. We report the estimand, the comparator, the withdrawal rate and the population, every time.
Everything filed here
SURMOUNT-4 was built to answer the stopping question, and it did
The regain trajectories, arm by arm, with the estimands named.
Maintenance dosing: what is licensed, what is practised, and what is evidenced
What the labels permit, what clinicians do, and the size of the gap between them.
STEP 4 extension data: what happens after the trial stops
A design note rather than a result: what the comparator was, and what that permits you to conclude.
What we would need to randomise to answer this properly
The older-adult diet-and-exercise trials are the closest analogue to rapid pharmacological weight loss, and they are twenty years old.
PIONEER 6 extension data: what happens after the trial stops
A design note rather than a result: what the comparator was, and what that permits you to conclude.
LEADER misses on a secondary endpoint the coverage has not mentioned
A design note rather than a result: what the comparator was, and what that permits you to conclude.
A reference interval is not a target, and a result outside one is not a diagnosis
Two sources of noise sit under every number: how reproducible the assay is, and how much the analyte varies within the same person on the same day.
STEP 4 misses on a secondary endpoint the coverage has not mentioned
A design note rather than a result: what the comparator was, and what that permits you to conclude.
SURPASS-3 misses on a secondary endpoint the coverage has not mentioned
A design note rather than a result: what the comparator was, and what that permits you to conclude.
SURPASS-4 misses on a secondary endpoint the coverage has not mentioned
A design note rather than a result: what the comparator was, and what that permits you to conclude.
What the outcome trials measured in the kidney
Asymptomatic pancreatic enzyme elevation is common on treatment and is not pancreatitis. The distinction is clinical, not biochemical.
FLOW extension data: what happens after the trial stops
A design note rather than a result: what the comparator was, and what that permits you to conclude.
SURPASS-3 extension data: what happens after the trial stops
A design note rather than a result: what the comparator was, and what that permits you to conclude.
What the trials monitored, and what that implies about routine practice
The argument for a baseline panel is that it makes every subsequent result interpretable. The argument against frequent monitoring is that noise accumulates faster than…
Reading the exenatide composition data without the press release
A substudy powered to describe a mean is not a substudy powered to detect a clinically meaningful individual change.
STEP 2 extension data: what happens after the trial stops
A design note rather than a result: what the comparator was, and what that permits you to conclude.
Side effects, cost, supply, target: four reasons with four trajectories
Real-world persistence figures, with their definitions stated, because the definitions are doing most of the work.
Side effects, cost, supply, target: four reasons with four trajectories
The trials studied planned withdrawal. Almost nobody stops that way.
SURMOUNT-OSA extension data: what happens after the trial stops
A design note rather than a result: what the comparator was, and what that permits you to conclude.