By Richard Kay

ISBN-10: 0470319712

ISBN-13: 9780470319710

Targeting the pharmaceutical non-statistician operating inside a truly strict regulatory surroundings, Statistical pondering for scientific Trials in Drug legislation offers the innovations and statistical considering at the back of clinical reviews with an instantaneous connection to the regulatory surroundings in order that readers should be transparent the place the statistical technique suits in with specifications. Pharmaceutical-related examples are used all through to set the data in context. The ebook offers a close assessment of the statistical points of the layout, behavior, research, and presentation of knowledge from scientific trials inside of drug rules.

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In some cases, of course, our measurement technique may only enable us to record to the nearest whole number (blood pressure for example), but that does not alter the basic fact that the underlying scale is continuous. Probably the second most common data type is binary. Examples of binary data include cured/not cured, responder/non-responder, died/survived. Here the measure is based on a dichotomy. Moving up from binary is categorical data where there are more than two categories that form the basis of the ‘measurement’.

Are viewed as exploratory. Indeed an alternative word for confirmatory is pivotal. It is the confirmatory elements of our trials that provide the pivotal information from a regulatory perspective. ’ Usually it is the primary endpoint(s) that provides the basis of the confirmatory claims and exploratory aspects are relegated to the secondary (or exploratory) endpoints. 10 Superiority, equivalence and non-inferiority trials A clear distinction should also be made between superiority, equivalence and non-inferiority trials.

This design is what we refer to as a between-patient design. The basis of the treatment comparison is the comparison between two independent groups of patients. An alternative design is the within-patient design. Such designs are not universally applicable but can be very powerful under certain circumstances. One form of the within-patient design is the paired design: • In ophthalmology; treatment A in the right eye, treatment B in the left eye • In a volunteer study in wound care; ‘create’ a wound on each forearm and use dressing of type A on the right forearm and dressing of type B on the left forearm Here the 50 subjects receiving A will be the same 50 subjects who receive B and the comparison of A and B in terms of say mean healing time in the second example is a comparison based on identical ‘groups’ of subjects.

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Statistical Thinking for Non-Statisticians in Drug Regulation by Richard Kay

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