Trials and Tribulations of N of 1 Trials - The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

N-of-1 trials share a common feature: they are single-subject study designs with the goal of determining how an individual patient responds to treatment intervention(s). These trials can take several forms, spanning different purposes and study populations, with their own distinctive advantages and challenges. The April 2023 Bioethics Collaborative focused on various ethical questions that arise in N-of-1 research: How do traditional research ethics principles and analyses, such as the concept of clinical equipoise and ‘social value,’ apply to N-of-1 research? How can the N-of-1 approach be generalized if each “trial” is unique to the individual? Is there a way to gain generalizable knowledge across several individual trials? How should costly N-of-1 research be prioritized against other research priorities? How do we decide, fairly and equitably, who has access to N-of-1 trials, particularly for rare or unique genetic conditions? How should we think about informed consent and make efforts to support it, given the potentially transformative nature of personalized interventions in particular?

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