Samuel Joyce P, Bell Cynthia S
Division of Pediatric Nephrology and Hypertension, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX.
Division of Pediatric Nephrology and Hypertension, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX.
Adv Chronic Kidney Dis. 2016 Nov;23(6):351-354. doi: 10.1053/j.ackd.2016.11.006.
Alternatives to the traditional parallel-group trial design may be required to answer clinical questions in special populations, rare conditions, or with limited resources. N-of-1 trials are a unique trial design which can inform personalized evidence-based decisions for the patient when data from traditional clinical trials are lacking or not generalizable. A concise overview of factorial design, cluster randomization, adaptive designs, crossover studies, and n-of-1 trials will be provided along with pertinent examples in nephrology. The indication for analysis strategies such as equivalence and noninferiority trials will be discussed, as well as analytic pitfalls.
