REWIND 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.
Yuki Morishita
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Archive — page 7
142 piecesEvery fortnight, every third week, seasonally: an unstudied practice
What the exposure arithmetic says about a fortnightly schedule, and where the arithmetic stops being informative.
A schedule that bends does not break
Every major phase 3 protocol in this class allowed escalation to be delayed for tolerability. Almost no product label explains the mechanics of doing so.
REWIND 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.
SURMOUNT-1 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-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.
Thiamine and the vomiting patient
Which markers are informative, which are confounded, and which move for reasons unrelated to nutrition.
Why your endoscopist wants to know about your injection
This is the single interaction with ordinary medical care that patients most need to disclose, and it is the one most often not asked about.
What a month without the drug does to tolerability
The convention — resume lower, re-escalate — is not caution. It follows directly from the elimination half-life.
TRIUMPH-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.
Why "muscle-sparing" is a marketing term and not a measurement
The gap between a defensible recommendation and a confident one is where most of the harm in this subject lives.
SURMOUNT-1 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.
SELECT 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.
The label says four weeks. The clinic says whatever holds.
What the regulatory dossiers actually contain on dose selection is remarkably thin, and worth knowing before treating the ladder as settled science.
TRIUMPH-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 outcome trials measured in the kidney
Asymptomatic pancreatic enzyme elevation is common on treatment and is not pancreatitis. The distinction is clinical, not biochemical.
Which results should be repeated before they are investigated
What the pivotal programmes measured and how often, which is a more defensible template than most published monitoring schedules.
TRIUMPH-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.
Why the bone question is harder than the muscle question
Weight loss reduces bone mineral density at load-bearing sites. Whether that translates into fractures in this population is unmeasured.
The glycated haemoglobin assay, and the eight conditions that break it
The assay is not the problem. The interpretation of a lagging integral as a current measurement is the problem.