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10.1016/j.cct.2014.09.005

http://scihub22266oqcxt.onion/10.1016/j.cct.2014.09.005
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suck abstract from ncbi


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pmid25308312
      Contemp+Clin+Trials 2014 ; 39 (2 ): 294-302
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  • Formulating appropriate statistical hypotheses for treatment comparison in clinical trial design and analysis #MMPMID25308312
  • Huang P ; Ou AH ; Piantadosi S ; Tan M
  • Contemp Clin Trials 2014[Nov]; 39 (2 ): 294-302 PMID25308312 show ga
  • We discuss the problem of properly defining treatment superiority through the specification of hypotheses in clinical trials. The need to precisely define the notion of superiority in a one-sided hypothesis test problem has been well recognized by many authors. Ideally designed null and alternative hypotheses should correspond to a partition of all possible scenarios of underlying true probability models P={P(?):???} such that the alternative hypothesis Ha={P(?):???a} can be inferred upon the rejection of null hypothesis Ho={P(?):???(o)} However, in many cases, tests are carried out and recommendations are made without a precise definition of superiority or a specification of alternative hypothesis. Moreover, in some applications, the union of probability models specified by the chosen null and alternative hypothesis does not constitute a completed model collection P (i.e., H(o)?H(a) is smaller than P). This not only imposes a strong non-validated assumption of the underlying true models, but also leads to different superiority claims depending on which test is used instead of scientific plausibility. Different ways to partition P fro testing treatment superiority often have different implications on sample size, power, and significance in both efficacy and comparative effectiveness trial design. Such differences are often overlooked. We provide a theoretical framework for evaluating the statistical properties of different specification of superiority in typical hypothesis testing. This can help investigators to select proper hypotheses for treatment comparison inclinical trial design.
  • |*Models, Statistical [MESH]
  • |*Research Design [MESH]
  • |Humans [MESH]
  • |Probability [MESH]


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