Results 11 to 20 of about 52,007 (260)
Trials, 2023 Background In a non-inferiority trial, the choice of margin depends on the expected control event risk. If the true risk differs from expected, power and interpretability of results can be affected. A non-inferiority frontier pre-specifies an appropriate
Matteo Quartagno +4 more
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Regional techniques for paediatric inguinal scrotal surgery. A randomized non-inferiority trial comparing low concentration caudal block versus ilioinguinal and iliohypogastric nerve block. [PDF]
Pediatric Anesthesia and Critical Care Journal (PACCJ), 2018 Introduction We have designed a prospective, randomised, single blinded non-inferiority trial to determine whether using a lower concentration local anaesthetic in caudal blocks (0.125% levobupivacaine) provides non-inferior analge- sia compared to IG ...
H-Y. Wong +4 more
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Regulatory scientific advice on non-inferiority drug trials.
PLoS ONE, 2013 The active-controlled trial with a non-inferiority design has gained popularity in recent years. However, non-inferiority trials present some methodological challenges, especially in determining the non-inferiority margin.
Grace Wangge +8 more
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Methodological standards in non-inferiority AIDS trials: moving from adherence to compliance
BMC Medical Research Methodology, 2006 Background The interpretation of the results of active-control trials regarding the efficacy and safety of a new drug is important for drug registration and following clinical use.
Verdon Renaud +2 more
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Contemporary Clinical Trials Communications, 2020 Background: Incomplete data analysis continues to be a major issue for non-inferiority clinical trials. Due to the steadily increasing use of non-inferiority study design, we believe this topic deserves an immediate attention.
Yulia Sidi, Ofer Harel
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Trials, 2021 Background Numerous statistical methods can be used to calculate the confidence interval (CI) of risk differences. There is consensus in previous literature that the Wald method should be discouraged.
Anthony D. Bai +12 more
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Non-inferiority trials and non-inferiority margin: an overview
International Journal of Epidemiology and Health Sciences, 2020 The randomized controlled trial (RCT) is considered the best interventional design to assess issues related to treatment and prevention. The RCTs can have different designs including superiority, equivalence, or non-inferiority design. A superiority trial aims to detect the potential superiority of new therapy compared to an active comparator or a ...
openaire +2 more sources
Trials, 2022 Background Non-inferiority trials are becoming increasingly popular in public health and clinical research. The choice of the non-inferiority margin is the cornerstone of such trials.
Arsene Brunelle Sandie +5 more
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Decrementally cost-effective health technologies in non-inferiority studies: A systematic review
Frontiers in Pharmacology, 2022 Background: HTA guidance has generally been driven by situations where innovative and usually more expensive technologies are compared to the prevailing standards of care.
Meryl Darlington +5 more
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Superiority and non-inferiority: two sides of the same coin?
Trials, 2018 Background The classification of phase 3 trials as superiority or non-inferiority has become routine, and it is widely accepted that there are important differences between the two types of trial in their design, analysis and interpretation.
David T. Dunn +2 more
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