Group sequential test strategies for superiority and non‐inferiority hypotheses in active controlled clinical trials

Wang, Sue‐Jane; Hung, H. M. James; Tsong, Yi; Lü, Chao

doi:10.1002/sim.820.abs

Cited by 20 publications

(41 citation statements)

References 10 publications

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“…Frequentist designs that simultaneously monitor efficacy and noninferiority have been suggested. 231 From a Bayesian perspective no special considerations are necessary, since at any time the posterior probability of lying in any region can be obtained and used for monitoring. However, as with looking for control benefit, one may want to be assured that the findings were convincing to an enthusiast for the new treatment.…”

Section: Convincing Evidence Of Equivalence or Non-inferiority In A mentioning

confidence: 99%

Issues in data monitoring and interim analysis of trials

Grant

Altman²,

Babiker³

et al. 2005

Health Technol Assess

144

175

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Section: Convincing Evidence Of Equivalence or Non-inferiority In A mentioning

confidence: 99%

Issues in data monitoring and interim analysis of trials

Grant

Altman²,

Babiker³

et al. 2005

Health Technol Assess

144

175

View full text Add to dashboard Cite

show abstract

“…Another strategy is via a non-inferiority argument that the experimental treatment is not much less effective than the active control and thus it would definitely have been superior to the placebo if the placebo had been studied in the trial. The statistical theory has concluded that testing superiority and non-inferiority simultaneously or in sequence of any order with the same confidence interval for the treatment effect does not require an alpha adjustment; that is, the maximum overall type I error rate associated with testing superiority and non-inferiority using the same confidence interval is at the targeted alpha level; see, e.g., Morikawa and Yoshida (1995), Wang et al (2001). However, this fact is only true if the non-inferiority margin does not depend on any data derived from the current trial; see Hung and Wang (2004).…”

Section: Changing From Superiority To Non-inferioritymentioning

confidence: 99%

A Regulatory View on Adaptive/Flexible Clinical Trial Design

Hung

O’Neill²,

Wang³

et al. 2006

Biometrical J

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Recently there is growing interest in use of adaptive or flexible designs for development of pharmaceutical products. Statistical methodology has been greatly advanced in the literature. However, there are still some important issues with the methodology and application. In addition, there are many other challenges with these designs, including efficiency of these designs in the entire development program, trial conduct and logistics, the infrastructure of an adaptive trial, the regulatory evaluation of trial results and trial conduct, etc. Up till now, regulatory experience in these designs is very limited. We share some of the challenges.

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“…As mentioned above, superiority and noninferiority have distinct testing principles, and adding superiority testing to noninferiority testing is not consistent with multiple comparison testing and can be done without loss of power and the need to adjust p values [28,37,38,61]. It also is valid to test for noninferiority for one (group of) end point(s) and for superiority in other end points in one study [28,36].…”

Section: Reason Explanationmentioning

confidence: 99%

Rationale for and Methods of Superiority, Noninferiority, or Equivalence Designs in Orthopaedic, Controlled Trials

Vavken

2011

Clinical Orthopaedics &Amp; Related Research

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Background To provide value-based healthcare in orthopaedics, controlled trials are needed to assess the comparative effectiveness of treatments. Typically comparative trials are based on superiority testing using statistical tests that produce a p value. However, as orthopaedic treatments continue to improve, superiority becomes more difficult to show and, perhaps, less important as margins of improvement shrink to clinically irrelevant levels. Alternative methods to compare groups in controlled trials are noninferiority and equivalence. It is important to equip the reader of the orthopaedic literature with the knowledge to understand and critically evaluate the methods and findings of trials attempting to establish superiority, noninferiority, and equivalence. Questions/purposes I will discuss supplemental and alternative methods to superiority for assessment of the outcome of controlled trials in the context of diminishing returns on new therapies over old ones. Methods The three methods-superiority, noninferiority, and equivalence-are presented and compared, with a discussion of implied pitfalls and problems.

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Group sequential test strategies for superiority and non‐inferiority hypotheses in active controlled clinical trials

Cited by 20 publications

References 10 publications

Issues in data monitoring and interim analysis of trials

Issues in data monitoring and interim analysis of trials

A Regulatory View on Adaptive/Flexible Clinical Trial Design

Rationale for and Methods of Superiority, Noninferiority, or Equivalence Designs in Orthopaedic, Controlled Trials

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