Personalized Data Science and Personalized (N-of-1) Trials: Promising Paradigms for Individualized Health Care.

The term 'data science' usually refers to the process of extracting value from obtained from a large group of individuals. An alternative rendition, which we call (Per-DS), aims to collect, analyze, and interpret to inform decisions. This article describes the main features of Per-DS, and reviews its current state and future outlook. A Per-DS investigation is of, by, and for an individual, the Per-DS investigator, acting simultaneously as her own , , and , and making decisions for study design and implementation. The scope of Per-DS studies may include systematic monitoring of physiological or behavioral patterns, case-crossover studies for symptom triggers, pre-post trials for exposure-outcome relationships, and personalized (N-of-1) trials for effectiveness. Per-DS studies produce generalizable to the individual's future self (thus benefiting herself) rather than knowledge generalizable to an external population (thus benefiting others). This endeavor requires a pivot from or to , analogous to home gardeners producing food for home consumption-the Per-DS investigator needs to ' by setting goals, specifying study design, identifying necessary data elements, and assembling instruments and tools for data collection. Then, she can implement the study protocol, harvest her personal data, and the data to personal knowledge. To facilitate Per-DS studies, Per-DS investigators need support from community-based, scientific, philanthropic, business, and government entities, to develop and deploy resources such as peer forums, mobile apps, 'virtual field guides,' and scientific and regulatory guidance.