title: Unique Study Designs in Nephrology: N-of-1 Trials and Other Designs.
abstract: 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.
authors.affiliation: Division of Pediatric Nephrology and Hypertension, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX. Electronic address: joyce.samuel@uth.tmc.edu.
authors.forename: Joyce P
authors.initials: JP
authors.lastname: Samuel
authors.affiliation: Division of Pediatric Nephrology and Hypertension, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX.
authors.forename: Cynthia S
authors.initials: CS
authors.lastname: Bell
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D015340:Epidemiologic Research Design; D006801:Humans; D009398:Nephrology / Q000379:methods*
keywords: Crossover studies; N-of-1 trial; Random allocation; Research design