N of 1 trial

Some N of 1 trials involve randomized assignment and blinding, but the order of experimental and control interventions can also be fixed by the researcher.

Many consider this framework to be a proof of concept or hypothesis generating process to inform subsequent, larger clinical trials.

[9] This design can be successfully implemented to determine optimal treatments for patients with diseases as diverse as osteoarthritis, chronic neuropathic pain and attention deficit hyperactivity disorder.

[11] There has also been work to adapt causal inference counterfactual methods for using N of 1 observational studies to design subsequent N of 1 trials.

[14] A famous proponent and active experimenter was Seth Roberts, who reported on his self-experimental findings on his blog, and later published The Shangri-La Diet based on his conclusions from these self-experiments.

Plot of a synthetic dataset from an A-A 1 -A N-of-1 trial: During day 1-30, day 61-90, and day 121-150, the participant is taking a drug developed to treat high blood pressure . They are taking a placebo in the remaining time. Normal systolic pressure is slightly below 120 (in mmHg).