Clinical Trial

A clinical trial is an interventional or observational  prospective research study involving human subjects that is designed to answer specific questions about biomedical (e.g., drugs, treatments, devices) or behavioral interventions (e.g., diet modifications, physical activity) through the compliant collection and analysis of safety and efficacy data as measurement for health outcomes.  In an interventional clinical trial, research subjects are assigned to a treatment or other intervention and their outcomes are measured.  In an observational clinical trial, interventions given during the course of clinical care are observed and outcomes are measured by the researchers.  Preclinical laboratory studies or studies in animals are not considered clinical trials.

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