Microbiology and Immunology 3300B Lecture 13: Clinical Case Studies
9 Dec 2016
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Clinical trials no questions on exam, just for understanding. Trials on humans intended to test whether a therapy is beneficial for treating a condition. Scurvy is a vitamin c deficiency first clinical trial was to test fixing this. As time went on it became more and more structured. Assess safety, efficacy, dosing, comparisons to existing treatments. Studies are either observational (diet, lifestyle, no intervention) or interventional (treatment) Always compare to placebo control, blind the trials both patients and research. Statistically strong enough study population to minimalize errors. Informed consent patie(cid:374)ts k(cid:374)o(cid:449) (cid:449)hat(cid:859)s happe(cid:374)i(cid:374)g, (cid:449)hat the risks are, and agree. Preclinical is testing in animals for efficacy. Phase 0 or pilot how quickly drug absorbs, how does it get broken down or secreted. Phase 1 small trial given to healthy people and the sole purpose is to figure out what dose is safe, look for common side effects. Phase 2 small number of patients given treatment look for efficacy and safety.
