This is a set of tools designed to simulate the output of different potential clinical trial designs, including N-of-1 style clinical trial designs, and evaluate their power and bias in detecting the relationship between a biomarker measured prior to the start of treatment and the efficacy of a particular treatment, including in the presence of various confounding effects, such as those related to expectancy or regression to the mean.
Please see the two vignettes to see how these tools were used to compare four basic clinical trial designs for use in a real-world biomedical scienario in order to select a clinical trial design currently underway.
Initial publication describing these methods is available open source: https://www.frontiersin.org/journals/digital-health/articles/10.3389/fdgth.2020.00013/full
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