Sample Size and the Ethics of Non-Inferiority Trials
Powers, John H.
Cooper, Charles K.
Ross, David B.
Lancet 2005 July 2-8; 366(9479): 24-25
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Nunn, Andrew J.; Meredith, Sarah K.; Spigelman, Melvin K.; Ginsberg, Ann M.; Gillespie, Stephen H.; Gandjour, Afschin; Soliman, Elsayed Z.; Chuang-Stein, Christy; Beltangady, Mohan; Dunne, Micahel; Morrison, Briggs; Menten, Joris; Boelaert, Marleen; Garattini, Silvio; Bertelé, Vittorio (2008-03-15)
Non-Inferiority Randomized Trials, an Issue Between Science and Ethics: The Case of the SYNTAX Study Mantovani, Vittorio; Lepore, Vincenzo; Mira, Antonietta; Berglin, Eva (2010-12)Non-inferiority trials are questionable when death and serious complications are included among outcomes. The term itself "non-inferiority" is misleading, since such a study would not demonstrate that a new treatment is ...