N-of-1 trials are within-patient, randomized, double-blind, cross-over comparisons of a treatment with either a placebo or another treatment (Nikles, 2015), where both effectiveness and safety the outcomes of interest. Lillie et al. (2011) and Schork (2015) have advocated use of n-of-1 trials to provide an individual patient treatment unique to his need, as envisioned in precision medicine. Kravitz et (2014) and Nikles and Mitchell (2015) published manuscripts to outline what n-of-1 trials are, the rationale for use of such trials in selected therapeutic areas, statistical and analytical considerations, and logistical, technological and financials aspects of these trials.

This round table will discuss how the statistical rigor of traditional randomized critical trials may be assured in the conduct of n-of-1 trials including design, randomization, statistical analysis and reporting to patients as well as health care providers and research professionals.