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British Journal of Clinical Pharmacology, ISSN 0306-5251, 2017, Volume 83, Issue 8, pp. 1636 - 1642
Journal Article
BMC MEDICAL RESEARCH METHODOLOGY, ISSN 1471-2288, 09/2019, Volume 19, Issue 1, pp. 1 - 13
Background: When conducing a non-inferiority Phase-III trial, regulatory agencies and investigators might want to get reliable information about rare but... 
TRIALS | Non-inferiority | HEALTH CARE SCIENCES & SERVICES | Mixture model | Clinical trial | Elicitation | Children | Bayesian inference | Pregnancy | Medical research | Newborn babies | Respiratory distress syndrome | Decision making | Research methodology | Clinical trials | Bayesian analysis
Journal Article
Headache: The Journal of Head and Face Pain, ISSN 0017-8748, 05/2017, Volume 57, Issue 5, pp. 729 - 736
Journal Article
Stroke, ISSN 0039-2499, 12/2019, Volume 50, Issue 12, pp. 3519 - 3526
BACKGROUND AND PURPOSE—Novel endovascular thrombectomy (EVT) devices for acute ischemic stroke are often cleared by regulatory agencies on the basis of... 
REVASCULARIZATION | MULTICENTER | thrombectomy | stroke | ASPIRATION | CLINICAL NEUROLOGY | NON-INFERIORITY | THERAPY | LARGE VESSEL OCCLUSION | STENT-RETRIEVER THROMBECTOMY | PERIPHERAL VASCULAR DISEASE | CLINICALLY IMPORTANT DIFFERENCE | humans | minimal clinically important difference | INTERVENTION | HEALTH-STATUS
Journal Article
Journal Article
Vaccine, ISSN 0264-410X, 2015, Volume 33, Issue 12, pp. 1426 - 1432
Journal Article
Annals of Statistics, ISSN 0090-5364, 02/2019, Volume 47, Issue 1, pp. 205 - 232
New nonparametric tests for the ordering of multiple survival functions are developed with the possibility of right censorship taken into account. The... 
Order-restricted inference | Equivalence test | Empirical likelihood | NON-INFERIORITY | TRIALS | DESIGN | CONFIDENCE-INTERVALS | equivalence test | order-restricted inference | STATISTICS & PROBABILITY | LIKELIHOOD-BASED TESTS | BANDS | PROBABILITIES
Journal Article
Statistical Methods in Medical Research, ISSN 0962-2802, 11/2019, Volume 28, Issue 10-11, pp. 3318 - 3332
Journal Article
Journal of Biopharmaceutical Statistics, ISSN 1054-3406, 11/2019, Volume 29, Issue 6, pp. 990 - 1002
The effect of reference treatment over placebo, known as M1, is essential in the development of non-inferiority margin. We proposed a M1 adjustment approach to... 
selection bias | non-inferiority margin | Effect size | simulation study | power analysis
Journal Article
Journal Article
Journal of Biopharmaceutical Statistics, ISSN 1054-3406, 09/2019, Volume 29, Issue 5, pp. 822 - 833
Non-inferiority comparison between binary response rates of test and reference treatments is often performed in clinical studies. The most common approach to... 
Non-inferiority test | variable margin | reference-scaled test | Wald test | binary response | NONZERO RISK DIFFERENCE | NULL HYPOTHESIS | TEST STATISTICS | PHARMACOLOGY & PHARMACY | STATISTICS & PROBABILITY | SAMPLE-SIZE FORMULAS | COMPARATIVE BINOMIAL TRIALS
Journal Article
Trials, ISSN 1745-6215, 2017, Volume 18, Issue 107, p. 1
BACKGROUND: There is no consensus on the preferred method for defining the non-inferiority margin in non-inferiority trials, and previous studies showed that... 
Methodology | Drug regulation | Non-inferiority margin | Non-inferiority trials
Journal Article
Journal of Clinical Epidemiology, ISSN 0895-4356, 2016, Volume 71, pp. 118 - 118
  [...]Soonawala et al. analyzed only trials published on core journals, whereas 45/57 of our trials were not published on core journals, which increased the... 
Internal Medicine | PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH | NON-INFERIORITY TRIALS | HEALTH CARE SCIENCES & SERVICES | Research Support as Topic - statistics & numerical data | Randomized Controlled Trials as Topic - economics | Drug Industry - economics
Journal Article