Noninferiority trials comparing new treatment with an active standard control are becoming increasingly common. This article discusses relevant issues regarding their need, design, analysis and interpretation: the appropriate choice of control group, types of noninferiority trial, ethical considerations, sample size determination and potential pitfalls to consider.

The term "design" encompasses all the structural aspects of a study, notably the definition of the study sample, size of sample, method of treatment allocation, type of statistical design (randomised, cross-over, sequential, etc), and choice of outcome measures. The importance of this stage cannot be overemphasised since no amount of clever analysis later will be able to compensate for major de...

Sample size estimation is a major component of the design of virtually every experiment in medicine. Prudent use of the available prior information is a crucial element of experimental planning. Most sample size formulae in current use employ this information only in the form of point estimates, even though it is usually more accurately expressed as a distribution over a range of values. In thi...

This paper shows how the probability, for a random confounding factor to reverse the estimate of ordinary regression, decreases exponentially with the sample size.

A random sample size version of the central limit theorem is obtained for a general class of symmetric statistics based on uniform spacings. An important application to goodness of fit test for a Poisson process is discussed.

We prove the following conjecture of Narayana: there are no nontrivial dominance reene-ments of the Smirnov two-sample test if and only if the two sample sizes are relatively prime. We also count the number of natural signiicance levels of the Smirnov two-sample test in terms of the sample sizes and relate this to the Narayana conjecture. In particular, Smirnov tests with relatively prime sampl...

OBJECTIVE To investigate the use of helmets for cyclists choosing to use BIXI bikes in comparison to personal bike riders in the City of Toronto. DESIGN Cross-sectional study design. SETTING Cyclists were observed in Toronto, Canada. PARTICIPANTS Of the 6732 sample size, 306 cyclists on BIXI bikes and 6426 personal bike riders were observed. OUTCOME MEASURE The outcome of interest was h...

This procedure computes power and sample size for non-inferiority tests in two-sample designs in which the outcome is a continuous normal random variable. Measurements are made on individuals that have been randomly assigned to one of two groups. This is sometimes referred to as a parallel-groups design. This design is used in situations such as the comparison of the income level of two regions...

In this paper we use simulations to compare the performance of new goodness-of-fit tests based on weighted statistical processes to three currently available tests: the Hosmer-Lemeshow decile-of-risk test; the Pearson chi-square, and the unweighted sum-of-squares tests. The simulations demonstrate that all tests have the correct size. The power for all tests to detect lack-of-fit due to an omit...