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Abstract:
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Advances in biomedical science have led to rapid replacement of "one size fits all" therapeutic strategies by a more individualized approach. While big data analytics have been deployed extensively in recent years for applications in personalized medicine, small data studies such as N-of-1 trials have the potential to further advance the methodological underpinnings of personalized medicine. In this roundtable session, we will discuss the conceptual framework for small data studies, particularly the design and implementation of N-of-1 trials - multiple cross-over trials within individual patients to inform each individual's own clinical or lifestyle decision-making. Broad applications of small data studies, including N-of-1 trials, have become feasible in recent years with advances in personal communication and information technologies. It is timely for the biostatistics community to begin to serve the needs of savvy consumers wanting to take an active role in enhancing their own health, as demonstrated in the extensive practice of self-tracking and self-experimentation among members of QuantifiedSelf.com. This is an emerging area in which biostatisticians can help transform healt
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