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An operational statistical definition of more

Imagine the following results from a superiority trial  [Pg.29]

The term treatment effect is an important one in drug development, and is defined as the difference between the average response to the investigational drug and the average response to the comparator being used in the trial. In this case of the development of a new antihyperten- [Pg.29]

We are about to introduce you to the concept of a statistically significant difference between the means of two sets of numbers. These numbers can be any kind of data, not just the clinical data that are the focus of this book. No matter how large or how small the difference found between the means of two sets of numbers, it is possible for that difference to be declared statistically significantly different after appropriate analysis of those data. In some circumstances and for some data, a difference of just one unit between the means of the two groups of data may indeed be found to be statistically significantly different, and in such a case the use of the term more would be statistically appropriate. [Pg.29]

However, in the context of clinical data, another extremely important concept is clinical significance. The clinical significance of a treatment effect is a completely separate assessment from the treatment effect s statistical significance. This is a clinical judgment, not the result of a single numerical calculation. It is perfectly possible for a treatment effect to be found to be statistically significant after an appropriate [Pg.29]


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