Statistical Aspects Of The Design And Analysis Of Clinical by Andrew Pickles, Brian S Everitt

By Andrew Pickles, Brian S Everitt

Totally up-to-date, this revised variation describes the statistical facets of either the layout and research of trials, with specific emphasis at the more moderen equipment of study. approximately 8000 medical trials are undertaken every year in all components of medication, from the remedy of zits to the prevention of melanoma. right interpretation of the knowledge from such trials relies principally on sufficient layout and on appearing the ideal statistical analyses. This ebook offers an invaluable consultant to scientific statisticians and others confronted with the customarily tough difficulties of designing and analysing scientific trials.

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Extra resources for Statistical Aspects Of The Design And Analysis Of Clinical Trials (Revised Edition)

Sample text

As Silverman (1985) put it: How is the impossible decision made to choose between the accepted standard treatment and the proposed improved approach when a fellow human being must be assigned to one of the two (or more) treatments 18 Treatment Allocation, the Size of Trials and Reporting Results 19 under test? Despite the most extensive pre-clinical studies, the first human allocation of a powerful treatment is largely a blind gamble and it is perhaps not surprising that so much has been written on the most appropriate fashion to allocate treatments in a trial.

The advantage of such a simple method is that each treatment assignment is completely unpredictable and in the long run the number of patients allocated to each treatment is unlikely to differ greatly. In the long run, however, implies a greater number of patients than are recruited to many clinical trials and it is of some interest to consider the chance of possible imbalance of patient numbers in the two groups. 01. 01. 5). Consequently, it is often desirable to restrict randomisation to ensure similar treatment numbers throughout the trial.

In addition to checking for compliance and noting possible adverse side effects, monitoring is also needed to assess whether early termination of the trial might be necessary. Early termination might be called for if there was an indication that the intervention was harmful to patients. Alternatively, if the data indicate a clear benefit from the intervention, the trial may need to be stopped early because to continue to use the control treatment would be unethical. 4. 2. OUTCOME MEASURES The outcome measure(s) used for treatment comparisons may be a clinical event, for example, death or recurrence of a disease, or a Monitoring Trial Progress 39 measurement of some other characteristics of interest, for example, blood pressure, serum lipid level or breathing difficulties.

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