Final answer:
The traditional/classical Fibonacci 3+3 dose escalation model is a method used in clinical trials to determine the optimal dose of a drug or treatment. It starts with three patients receiving the lowest dose, and if no adverse effects are observed, the dose is increased for the next three patients until the maximum tolerated dose or desired efficacy is reached.
Step-by-step explanation:
The traditional/classical Fibonacci 3+3 dose escalation model is a method used in clinical trials to determine the optimal dose of a drug or treatment. In this model, the trial starts with three patients receiving the lowest dose of the treatment. If no significant adverse effects are observed, the dose is escalated for the next three patients. This process continues until the maximum tolerated dose or desired efficacy is reached.
For example, let's say we have a new experimental drug for cancer treatment. The initial dose is set at 100 mg. The first three patients receive this dose, and if none of them experience severe side effects, the dose is increased to 200 mg for the next three patients. This escalation continues until the maximum tolerated dose is found or the desired efficacy is achieved.
The Fibonacci sequence, which follows a pattern of adding the two previous numbers to get the next number (1, 1, 2, 3, 5, 8, ...), is used in this model to determine the number of patients at each dose level. The total number of patients needed for the trial is a multiple of three.