题目内容

As defined by US HHS regulations: "Intervention" refers to ________________________ by which data is gathered and the manipulation of the subject and/or their environment for research purposes.

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AsdefinedbyUSHHSregulations:"Interaction"referstocommunicationorinterpersonalcontactbetween _______________________.

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."

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.