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Unformatted text preview: Handout 1: Introduction to Clinical Trials Definition : A clinical trial is an experiment testing medical treatments on human subjects. 1. An experiment means that key features - what treatment, for how long, what outcome, who participates- are planned and controlled by the investigator. 2. A trial studies medical treatments , that is, the goal is to cure, delay progression of, relieve symptoms of, or prevent a disease or medical problem. 3. Clinical implies human subjects , thus not animal or tissue cultures, though these may precede or accom- pany a trial. Clinical research has many aspects. Ahrens  laid out a typology. Lets look at some AIDS research background to illustrate the typology. 1 . Studies of disease mechanisms. Observation, laboratory. Example: discovery of HIV as mechanism of AIDS. The syndrome was described and was found to infect T cells. Found to be communicable, via blood and semen. Pattern suggested a retroviral origin. Discovery by Montagnier and Gallo (maybe not independently) of HIV. 2. Studies of disease management. Includes prevention and treatment, by drugs, devices, public health measures. Example: Zidovudine, the first approved treatment for AIDS. A randomized, double-blind, placebo- controlled trial in 282 patients with AIDS; 145 got AZT, 137 placebo. Nineteen patients on placebo died, 1 on AZT. Study was terminated early and all patients put on AZT. Secondary measures: Karnofsky score increased, CD4 count went up, fewer opportunistic infections....
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- Winter '06
- Epidemiology, Clinical trial