We usually think of using clinical trials in the context of evaluating new
treatments (drugs, surgery, devices, etc.). The clinical trial model is the
best method for clarifying the safety and efficacy of an experimental
treatment before it is approved and before it becomes the standard of care
in the community. In this same context, in recognition of the truism that
'medical practice does not change on the basis of one study,' clinical trials
may be useful in providing confirmatory evidence of safety and efficacy after
the new treatment has been introduced.
The methodology is also suited to evaluating many other aspects of health
care, including prevention strategies, public health screening programs for
disease, and methods of distribution of health resources. The clinical trial
method provides the scientific basis for evaluation of the benefits as well
as the risks of new health care technology.
This lecture will focus on the issue of evaluating new treatments; however,
the principles remain essentially the same for all applications of the
clinical trial method.