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The aim of an equivalence trial is to show the therapeutic equivalence of two treatments, usually a new drug under development and an existing drug for the same disease used as a standard active comparator. Unfortunately the principles that govern the design, conduct, and analysis of equivalence trials are not as well understood as they should be.(More)
The opportunity to write a truly international guideline on statistics is a rare one indeed. In 1995, the Steering Committee of the International Conference on Harmonisation1 (ICH) took a decision which was of major importance to all medical statisticians involved in the development of new medicinal products. This decision was to add a guideline on(More)
When a clinical trial is conducted at more than one centre it is likely that the true treatment effect will not be identical at each centre. In other words there will be some degree of treatment-by-centre interaction. A number of alternative approaches for dealing with this have been suggested in the literature. These include frequentist approaches with a(More)
Clinical trials of new drugs in the treatment of angina pectoris frequently make use of exercise tests to evaluate efficacy. The crossover design is often employed. The methods commonly used to analyse the various exercise times, for example, 'time to pain', are insensitive and potentially biased by the manner in which they deal with the censored nature of(More)
This paper concerns the statistical work carried out with respect to clinical trials conducted for regulatory purposes. Although the general quality of such work has improved markedly over recent years and is now generally high, a number of shortcomings remain. A few of these arise from failure to follow well established statistical practice. Rather more(More)
In recent years the Artificial Intelligence research group at the University of New Mexico have considered several areas of problem solving in interesting and complex domains. These areas have ranged from the low level explorations of a robot tasked to explore, map, and use a new environment to the development of very sophisticated control algorithms for(More)