PHLB09H3 Lecture Notes - Lecture 8: Institutional Review Board
Document Summary
Safety of the drug and its effectiveness. Week 5 lecture #8: tuesday september 29, 2015. Main factor in change: placebo control group. Greater improvement in experimental subjects: active control group; E. g. , researcher giving treatment to healthier subjects. Not greater than those received in placebo --> not effective. Long term, after it"s been on the market for a while. Main concern is safety of drug, so given small amount: large, efficacy, larger, therapeutic, comparative efficacy, side effects. No treatment at all (placebo), not given absolute best care they could have. Other disputes about ct: sacrifice patient interest for study. Fine if no evidence for preference: doctors owe preference equipoise is wrong. Owe their honest opinions, have to tell them what"s best. Lack of evidence to what else is best. Constrain on autonomy, if no other treatments available. Has to know they"re participating in the trial. Not a lot of benefit, but no other treatments.