"The FDA allows Imugene to recruit between 3 - 6 patients per cohort in some of their trials, only to find its always closer to 3 enrolled"
The 3+3 cohort design is a widely used approach in early-phase clinical trials.
It is considered to be a practical and straightforward method for determining the maximum tolerated dose (MTD) of investigational drugs or treatments.
The 3+3 design involves enrolling patients in cohorts (batches) with increasing doses.
Each cohort consists of three patients initially.
The goal is to identify the highest dose level that does not cause unacceptable toxicity.
The trial starts with the lowest planned dose, If no significant toxicity (dose-limiting toxicity, or DLT) is observed in the first cohort, the trial proceeds to the next higher dose.
Only if a DLT occurs, additional patients are enrolled at the same dose level.
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