PHLB09H3 Lecture 8: PHLB09 LECTURE 8
Document Summary
Two consequences: progress, abuse (untreated, undisclosed, infection, experimentation) Clinical trials: tests medical intervention in humans, determines safety/effectiveness. Desiderata of trial: max. objectivity, min. bias. The chance of bias exists, it can be exploited: avoiding error. Blinding: ignorance about treatment (placebo, new, old) Randomization: assignment of subjects to groups. Trial phases: 1: small, safety, no benefit, 2: large, efficacy, 3: larger, therapeutic, comparative efficacy, 4: side effects. September 29th 2015: low risk, fair subject selection, privacy/confidentiality, approved research. Balance of a, b, and j: autonomy- informed consent; beneficence- existing risks; justice- who gets the treatment/placebo. Ct conflict with a and b: subjects as means to inquiry, control group entails less-than-best/no treatment. Response: subjects can be useful and respected, doctor"s secondary duty is as researcher. The whole purpose of ct is to find evidence: 2. Doctors owe preference equipoise rational position of deliberation; balance of interests is wrong.
