A clinical trial is a prospective study that involves human subjects in which an intervention is to be [Page 156]evaluated. In a clinical trial, subjects are followed from a well-defined starting point or baseline. The goal of a clinical trial is to determine whether a cause-and-effect relationship exists between the intervention and response. Examples of interventions used in clinical trials include drugs, surgery, medical devices, and education and subject management strategies. In each of these cases, clinical trials are conducted to evaluate both the beneficial and harmful effects of the new intervention on human subjects before it is made available to the population of interest. Special considerations for conducting clinical trials include subject safety and informed consent, subject compliance, and intervention strategies to avoid bias. ...
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