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We calculated sample size considering the costs of implementing the results of the trial and the trial costs using (1) Neyman\u2014Pearson methods and (2) a Bayesian cost\u2014benefit method. We illustrate these methods in a clinical trial sponsored by the National Institutes of Health that compares two levels of blood urea nitrogen clearance by haemodialysis for patients with end\u2010stage renal disease. When applied to evaluations of research proposals, these methods may help researchers to decide whether to begin a study, and, if so, how many subjects to enrol in it. These methods should be especially useful for large studies intended to inform health policy.<\/jats:p>","DOI":"10.1002\/sim.4780142008","type":"journal-article","created":{"date-parts":[[2007,4,29]],"date-time":"2007-04-29T10:16:43Z","timestamp":1177841803000},"page":"2249-2259","source":"Crossref","is-referenced-by-count":37,"title":["Designing a cost\u2010effective clinical trial"],"prefix":"10.1002","volume":"14","author":[{"given":"John C.","family":"Hornberger","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"suffix":"Jr.","given":"Byron Wm.","family":"Brown","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jerry","family":"Halpern","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2007,2,28]]},"reference":[{"key":"e_1_2_1_2_2","volume-title":"Reduction in mortality and morbidity among hemodialysis patients","author":"National Institute of Diabetes and Digestive and Kidney Diseases","year":"1991"},{"issue":"13","key":"e_1_2_1_3_2","first-page":"S101","article-title":"Modeling success or failure of dialysis therapy: The National Cooperative Dialysis Study","volume":"23","author":"Laird N. 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