HLTH333 Lecture Notes - Lecture 7: Takers, Pharmaceutical Industry, Sample Size Determination
24 Oct 2016
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Randomized comparison of two or more groups to evaluate medical interventions. Evaluate new interventions before getting regulatory approval? i. Is the drug better than current therapies? i. All studies are done in-vitro or on animals to assess potential for drug. Done on healthy volunteers to ensure it is safe to give to unhealthy poeple. The purpose it to asses the toxicity and pharmological effects. Drug is introduced to diseased individuals to see results. Everybody has the disease and everybody gets the drug. Can be multiple phase 2 studies or one large one. Randomized control trilas where some people take the new drug and others take a placebo. Continuation and follow up of rct subjects past the official end of the rct. Phase 3 trials are over a short period of time. Phase 4 tracks these individuals over a longer period of time to see how it effects the patient long term.
