AtlasSession 3L9: Variations in study designp.27
Dose escalation (3+3)
- Study designs primer
- Classification
- Cohort studies
- Randomised controlled trials
- Dose escalation (3+3)
Fig. 1
Knee osteoarthritis, first-in-human MSC injections: a dose ladder of 10, 25, 50 and 100 million cells, 3 patients at a time
Fig. 1. Dose ladder, cohorts of 3 with serious reactions: dose 1: 0/3. 3 patients so far.
- Dose now
- dose 1 (10 million cells)
- Serious reactions
- 0 of 3
- Next
- higher dose
- Patients so far
- 3
Trial Design Board · First look
already at the first group of 3nothing marked yet
the run stops at cohort 4
Level 1 · First look · Lecture 9 · p.27
Understand climbing a dose ladder carefully, a few patients at a time.
Apply the 3+3 rules to decide whether to escalate, expand or step down, and identify the maximum tolerated dose.
Chilli ladder (the step you are on)
Try a mild chilli with three friends; move hotter only if nobody suffers.
Like trying a mild chilli with three friends and going hotter only if nobody suffers, three patients start on the lowest dose: dose 1 (10 million cells).