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.
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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.
Hippocrates believed that diseases result from imbalances of different substances (such as blood, phlegm, and mucous) in the body, and most of the Hippocratic interventions were aimed at restoring the body's natural balance and helping the body ______________.
Hippocrates developed a medical ethos known as the Hippocratic Oath. One of the key tenets of the Oath is: "I will use those dietary regimens which will benefit my patients according to my greatest ability and judgement, and I will do no harm or injustice to them." Others have simplified this part of the Oath to the principle of non-maleficence ("do no harm") and the principle of ___________________ ("benefit your patient").