MEDRADSC 3X03 Lecture Notes - Lecture 17: Case Series, Cohort Study, Informed Consent
6 Mar 2020
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Lecture #17: experimental studies randomized control trials (rct. Phase 1: test drug on healthy subjects (tens) to determine dose that can safely be tolerated. Phase 2: test drug on subjects with the condition (hundreds) at levels similar to phase 1 to see if the drug has any effect. Phase 3: test drug against gold standard to determine efficacy & safely. Phase 4: long term efficacy & safety (thousands); compare drug to gold standard, look to long term efficacy & safely. Intervention studies raise special ethical concerns bc the researcher is assigning participants to exposures. Equipoise: an experiment should only be conducted when there is genuine uncertainty about the outcome. Placebo: an inactive comparison that is similar to the therapy being tested. Some studies may compare the new therapy to some existing standard of care. Various combinations of doses & drations of an intervention can be compared using a factorial design.
