Philosophy 2715F/G Lecture 7: February 28 - Clinical Equipoise and Research
Document Summary
Randomized controlled trials: how can these ever be ethical where a doctor is recommending this to a patient, these study results/procedures tend to be consistent with the standard of care. Definition: relationships of structural inequality in which the fiduciary is granted discretionary power over a significant practical interest of a beneficiary: doctor to vulnerable patient. Vulnerability of the beneficiary leads to fiduciary duties. Fiduciary duties protects the beneficiary from harm that may result from conflicts of interest, neglect or negligence. Duty of care: duty to act and advise so as to promote the medical interest of the patient. Standard of care as a specification of the duty of care: treatment endorsed by at least a respectable minority of expert practitioners. Potential drug of use is identified: plants, lab or modeling. Testing in animal models: safety, efficacy, pharmacokinetics. Phase 1 trials: establishing preliminary safety, establish dosing, 10"s of patients. Phase 2 trials: establish efficacy, 10-100 patients.