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NIH defines a clinical trial as "A research study in which one or more human subjects are prospectively assigned to one or more __________________ (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes."

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Prior to establishing the efficacy of an experimental treatment for a given condition, researchers typically need to identify the _______ of the condition, possible mechanisms for treating it, a safe and effective dose, and ways of testing whether the drug is having an effect on the disease.

Successful phase 2 studies are followed by phase 3 studies which involve hundreds, sometimes thousands of patients. Phase 3 studies are designed to provide a rigorous test of the efficacy of a treatment and frequently involve ___________________ of subjects to the new treatment or a control, which might be standard existing treatment or a placebo.

Clinical trials of experimental treatments typically include purely ________________________, such as blood draws, imaging scans, or biopsies, that are performed to collect data regarding the treatment under study.

A clinical trial/study is any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its ________ and/or efficacy.