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N-Of-1 Trial

Meaning

An N-Of-1 Trial is a specialized, highly rigorous clinical trial design where a single individual patient constitutes the entire study population, effectively serving as their own control. In this methodology, the patient receives an intervention, such as a specific hormonal agent or dose, followed by a placebo or an alternative treatment, with multiple crossover periods conducted in a randomized and blinded fashion. This design is exceptionally valuable in precision medicine and hormonal health for definitively determining the optimal therapeutic regimen and dose for an individual patient, effectively addressing the challenge of population-level heterogeneity.