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Non-inferiority trials

BMJ, 2011
Researchers investigated the efficacy and safety of oral pristinamycin for the treatment of erysipelas in patients admitted to hospital. A multicentre, randomised controlled non-inferiority trial was performed.1 The control treatment was penicillin, the standard treatment for erysipelas in adults.
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Remaining Challenges in Assessing Non-Inferiority

Therapeutic Innovation & Regulatory Science, 2014
Despite decades of experience with non-inferiority trials, they remain a source of great controversy and involve fundamental areas of disagreement. Indeed, there can be little more fundamental than the definition of the hypothesis to be tested, and yet it can be argued that the null hypothesis commonly used in these trials, which involves specification
Steven, Snapinn, Qi, Jiang
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[Non-inferiority trials].

Giornale italiano di cardiologia (2006)
Superiority trials are designed to test the hypothesis that a given diagnostic or therapeutic strategy is better than (i.e. "superior to") placebo or an active control. Conversely, non-inferiority trials test the hypothesis that a newer (i.e. alternative) strategy is not "unacceptably worse" than a control (i.e. "traditional", or "older") strategy. Non-
Angeli F.   +6 more
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Non‐Inferiority Testing with a Variable Margin

Biometrical Journal, 2006
AbstractThere has been growing interest, when comparing an experimental treatment with an active control with respect to a binary outcome, in allowing the non‐inferiority margin to depend on the unknown success rate in the control group. It does not seem universally recognized, however, that the statistical test should appropriately adjust for the ...
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Simultaneous confidence intervals on multivariate non‐inferiority

Statistics in Medicine, 2012
We discuss the analysis of non‐inferiority trials based on a multi‐armed design with multiple correlated endpoints. We consider five different scenarios: (1) global non‐inferiority; (2) non‐inferiority for subsets of comparisons; (3) global non‐inferiority for a treatment group; (4) global non‐inferiority for an endpoint; and (5) local non‐inferiority.
Hasler, M., Hothorn, L. A.
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Non-Inferiority Trials

2012
This chapter focuses on the challenges presented by therapeutic targets in the central nervous system (CNS), the manner in which animal models have and can be used to support the translation of therapeutic biologies to the human CNS, the blood brain barrier (BBB), and the uncertainties of CNS drug exposures.
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Non-Inferiority Trials

Sang thrombose vaisseaux, 2021
Caroline Elie, Emmanuel Touzé
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Tests for equivalence or non-inferiority – why?

Drug and Therapeutics Bulletin, 2008
Drugs are sometimes assessed in clinical trials designed to test their equivalence or non-inferiority to a standard therapy. Non-inferiority trials, in particular, appear to be increasingly used to test new drugs, such as the oral hypoglycaemics reviewed in this issue of DTB.1 Here we summarise the main features of equivalence and non-inferiority ...
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Current issues in non‐inferiority trials

Statistics in Medicine, 2007
AbstractNon‐inferiority (NI) trials enable a direct comparison of the relative benefit‐to‐risk profiles of an experimental intervention and a standard‐of‐care regimen. When the standard has clinical efficacy of substantial magnitude that is precisely estimated ideally using data from multiple adequate and well‐controlled trials, with such estimates ...
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