Clinical trials are one form of clinical research that involves a researcher or researchers who directly observe a person or people, and/or who collect data to answer a scientific or medical question about the safety or potential benefit of an intervention such as a medication, device, teaching concept, training method, or behavioral change. There are several definitions of clinical trial, some of which are explained below.
Clinical trials are designed to provide information about different types of outcomes.
Some studies combine a PK component and a PD component.
An additional category of clinical trials—called efficacy studies—establish the overall risks and benefits of any intervention. These studies must be of large enough size and must incorporate the proper design to allow the results to be analyzed and generalized, or applied to the general population.
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