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Non-inferiority trials

Perspectives in Clinical Research, 2022
Studies sometimes aim to show that a new intervention is not substantially worse than the existing standard of care while offering some benefits, for example, lower cost, decreased toxicity, or easier administration.
Priya Ranganathan, C S Pramesh, Rakesh Aggarwal   +2 more
doaj   +3 more sources

Testing for non-inferior mortality: a systematic review of non-inferiority margin sizes and trial characteristics [PDF]

BMJ Open, 2021
Objective To describe the size and variability of non-inferiority margins used in non-inferiority trials of medications with primary outcomes involving mortality, and to examine the association between trial characteristics and non-inferiority margin ...
Nick Daneman, Robert A Fowler, Sandra Pong, Martin Urner, Nicholas Mitsakakis, Winnie Seto, James S Hutchison, Michelle Science   +7 more
doaj   +3 more sources

Design of phase II non-inferiority trials

Contemporary Clinical Trials Communications, 2017
With the development of inexpensive treatment regimens and less invasive surgical procedures, we are confronted with non-inferiority study objectives.
Sin-Ho Jung
doaj   +3 more sources

Tackling control risk problems in non-inferiority trials [PDF]

BMJ Medicine
Non-inferiority trials aim to show that major disease related outcomes with a new intervention are not importantly worse than with standard care. These trials are useful when the new intervention has some advantages over standard care (eg, toxicity ...
A Sarah Walker, Ian R White, Matteo Quartagno, Rebecca M Turner, Mahesh Kb Parmar, Abdel G Babiker   +5 more
doaj   +2 more sources

The YOMEGA non-inferiority trial [PDF]

The Lancet, 2019
International ...
Bergeat, Damien, Sulpice, Laurent, Meunier, B., Boudjema, Karim, Naudet, Florian   +4 more
  +11 more sources

Tutorial on non inferiority trial in pharmaceutical research: an important and applied issue [PDF]

Saudi Pharmaceutical Journal
Farzan Madadizadeh, Golnaz Afzal
doaj   +2 more sources

Testing of Hypothesis in Equivalence and Non Inferiority Trials-A Concept [PDF]

Journal of Clinical and Diagnostic Research, 2016
Establishing the appropriate hypothesis is one of the important steps for carrying out the statistical tests/analysis. Its understanding is important for interpreting the results of statistical analysis. The current communication attempts to provide the
Atul Juneja, Abha R. Aggarwal, Tulsi Adhikari, Arvind Pandey   +3 more
doaj   +1 more source

Non-inferiority clinical trials: importance and applications in health sciences [PDF]

Brazilian Oral Research, 2020
Non-inferiority randomized clinical trials are indicated when it is intended to prove that an experimental group is not inferior to a control group by more than a margin of non-inferiority.
Heitor Marques HONÓRIO, Linda WANG, Daniela RIOS   +2 more
doaj   +1 more source

Conducting the non-inferiority test for the means with unknown coefficient of variation in a three-arm trial

BMC Medical Research Methodology, 2023
Background The non-inferiority test is a reasonable approach to assessing a new treatment in a three-arm trial. The three-arm trial consists of a placebo, reference, and an experimental treatment.
Meng-Chih Lee, Wei-Ya Wu, Hung-Yi Lu, Hsin-Neng Hsieh, Wei-Hwa Wu   +4 more
doaj   +1 more source

Comparison of modafinil and pitolisant in narcolepsy: a non-inferiority metaanalytical approach

Drugs in Context, 2020
Aim: To assess the non-inferiority of pitolisant, a new compound for the relief of excessive daytime sleepiness (EDS) and cataplexy in narcolepsy, compared with modafinil.
Philippe Lehert, Cassandra Szoeke
doaj   +1 more source