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Conceptually, evaluation of a new intervention begins with a research
question, often framed in the form of a hypothesis. To conduct a clinical
trial of a new treatment, the target population must be defined; the
specific intervention, including how it is to be implemented, must be
determined; and, most importantly, criteria for determining treatment
benefit must be delineated. Some guidelines in these areas, as well as
some practical issues in the design and conduct of a clinical trial, will be
discussed in this lecture.
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