Feb 24, 2013

N-of-1 | single subject clinical trials

The interest in evidence-based, as well as individualized medicine, has led to some very notable discoveries.

An N of 1 trial is a clinical trial in which an individual patient as the sole unit of observation in a study investigating the efficacy or side-effect profiles of different interventions. A trial in which random allocation can be used to determine the order in which an experimental and a control intervention are given to a patient is an N of 1 randomized controlled trial. The order of experimental and control interventions can also be fixed by the researcher.

The ultimate goal of an n-of-1 trial is to determine the optimal or best intervention for an individual patient using objective data-driven criteria. Such trials can leverage study design and statistical techniques associated with standard population-based clinical trials, including randomization, washout and crossover periods, as well as placebo controls. The single case experimental design has been very effective in psychology and other field of behavior science.

ref: Wikipedia

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