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Assay sensitivity for a non-inferiority trial may depend upon the chosen margin of inferiority ruled out by the trial, and the design of the planned non-inferiority trial. The chosen margin of inferiority in a non-inferiority trial cannot be larger than the largest effect size which the control intervention reliably and reproducibly ...
Randomized controlled trial [5]. Blind trial [6]; Non-blind trial [7]; Adaptive clinical trial [8]. Platform Trials; Nonrandomized trial (quasi-experiment) [9]. Interrupted time series design [10] (measures on a sample or a series of samples from the same population are obtained several times before and after a manipulated event or a naturally occurring event) - considered a type of quasi ...
An example would be switch from a superiority to a non-inferiority design. Group sequential Sample size, by a set interval at a time. Sample sizes can be changed. These trials usually change the sample size by adding or removing set-blocks of patients such as adding 20 patients at a time, and then re-evaluating.
Non-inferiority trial A trial with the primary objective of showing that the response to the investigational product is not clinically inferior to a comparative agent (active or placebo control). (ICH E9) Nonrandomized clinical trial A clinical trial in which the participants are not assigned by chance to different treatment groups.
It also incorporates outranking rationale to deal with the 'poor' true-criteria preference structure which appears in selecting proper equipment. The superiority and inferiority scores are produced through the generalized criteria. The SIR method can also analyze different criteria without compiling them into a small scale as GAs.
The logrank test statistic compares estimates of the hazard functions of the two groups at each observed event time. It is constructed by computing the observed and expected number of events in one of the groups at each observed event time and then adding these to obtain an overall summary across all-time points where there is an event.
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A very simple equivalence testing approach is the ‘two one-sided t-tests’ (TOST) procedure. [11] In the TOST procedure an upper (Δ U) and lower (–Δ L) equivalence bound is specified based on the smallest effect size of interest (e.g., a positive or negative difference of d = 0.3).