Selection of Subjects Maximizing the Signaltonoise Ratio

Clinical trials are very expensive undertakings. Also, because they involve human subjects, there is always an ethical imperative to use the subject resources judiciously. Often, the researcher has only one chance to conduct a trial designed to answer a given question. Thus, the efficiency of the trial design is critical. In other words, the design must be such that the signal-to-noise ratio is maximized. The selection of subjects by specifying certain inclusion and exclusion criteria may go a long way in this direction. The exclusion of patients with poor prognosis who are unlikely to respond to treatment, the inclusion of only patients with more than minimal severity of their condition, and similar measures, are often used to achieve this goal. Again, one must be careful not to narrow the subject population to the extent that the results could not be generalized to a broader patient population.

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