A false set of non-IV clinical trial design and analysis of.docVIP

 PAGE \* MERGEFORMAT 3 A false set of non-IV clinical trial design and analysis of Author: Cheng Hao-wei Sun Aimin Zhao Guolong [Keywords:] non-virtual Abstract: Objective: This paper presents a false set of non-IV clinical trial design and analysis. Methods: According to the treatment control difference and the smallest amount of an identifiable difference comparison of the establishment of non-null set. Each center will be in clinical trials as a layer to layer samples of the weighted average score of the right to make a consolidated treatment of the control difference and its expectation and variance. Thus construct a false set of non-hierarchical design of some basic relationship, and then deduce a false set of non-IV clinical trials and the sample size required to test statistic. Monte Carlo methods in order to demonstrate their behavior. Results: When the minimum amount of identifiable difference to take 0:00, it is false to restore the traditional IV-based Phase I clinical trials sample size requirements and the test statistic and its observed effects consistent with the intended effect. Conclusion: This clinical trial can be used to establish test drugs for effective control of clinical priority or non-inferiority effect. Keywords:: effective control; clinical trial; MonteCarlo method; non-null set; stratification 1 Introduction A false set of non-drug treatment can make a more reasonable interpretation of [1 ~ 5], this clinical trial design, execution and analysis put forward higher requirements [6,7]. The outstanding feature is the introduction of effective control [8 ~ 10], to create a test drug for effective control of clinical priority or non-inferiority effect [11 ~ 16]. Phase IV clinical trials focused on post-marketing evaluation for drug, generally by comparing the samples with the overall statistical inference. In recent years, multi-center clinical trials are mostly used methods, each center is often seen as a layer of pre-stratified ra