By Mark D. Rothmann, Rothmann
The elevated use of non-inferiority research has been followed via a proliferation of study at the layout and research of non-inferiority reports. utilizing examples from actual medical trials, layout and research of Non-Inferiority Trials brings jointly this physique of study and confronts the problems interested by the layout of a non-inferiority trial. each one bankruptcy starts with a non-technical advent, making the textual content simply understood by means of these with no previous wisdom of this sort of trial. subject matters lined contain: numerous problems with non-inferiority trials, together with a number of comparisons, lacking info, research inhabitants, using defense margins, the inner consistency of non-inferiority inference, using surrogate endpoints, trial tracking, and equivalence trials particular concerns and research equipment while the information are binary, non-stop, and time-to-event The historical past of non-inferiority trials and the layout and behavior issues for a non-inferiority trial The energy of proof of an efficacy discovering and the way to judge the impact measurement of an energetic regulate remedy A entire dialogue at the function and concerns concerned with non-inferiority trials, layout and research of Non-inferiority Trials will support present and destiny scientists and statisticians at the optimum layout of non-inferiority trials and in assessing the standard of non-inferiority comparisons performed in perform.
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Extra info for Design and Analysis of Non-Inferiority Trials (Chapman & Hall CRC Biostatistics Series)
4. Three hundred subjects are randomly divided among the experimental and control arms. 15 when there is a common cure rate between 80% and 90%. Suppose 112 (75%) patients on the experimental arm and 121 (81%) patients on the control arm are cured. 15, and thus non-inferiority is not demonstrated. However, had the control cure rate been 2% lower and the experimental cure rate been 6% lower, non-inferiority would have been demonstrated; in fact, the results would have statistically demonstrated that the experimental arm has an inferior cure rate when compared with the control arm.
A quality non-inferiority inference depends largely on the ability to estimate or quantify the effect of the active control therapy within the setting of the non-inferiority trial. This is usually done in the absence of a placebo arm in the non-inferiority trial and on the basis of the results from past clinical trials evaluating the effect of the active control. A value that is small compared to background variability or has other good statistical properties Wiens3 discussed three considerations for choosing a non-inferiority margin/criterion: comparison with putative placebo, the clinical importance of the active control effect, and statistical considerations.
Sensitivity analyses should be prespecified to the extent possible. While sensitivity analyses are recommended, the use of sensitivity analyses is not a substitute for poor trial conduct or poor adherence to protocol, and does not rescue the results of a poor-quality clinical trial. It is thus important that the conduct of the non-inferiority trial be of high quality so as to not compromise the non-inferiority comparison by either obscuring differences in the effects of the study arms on the endpoint of interest, or being so dissimilar to the study conduct of those previous trials whose results were used to establish the non-inferiority criterion so as to make the non-inferiority margin irrelevant.
Design and Analysis of Non-Inferiority Trials (Chapman & Hall CRC Biostatistics Series) by Mark D. Rothmann, Rothmann