BIOM1060 Lecture 15: Quality use of medicines - Critical evidence and therapeutic decisions (BIOM1061)
Document Summary
Therapeutic decision: benefits of intervention outweigh harms. Efficacy: intervention possesses proposed benefits in defined population. Effectiveness: intervention possesses proposed benefits in patients under routine care. Adverse drug reactions: harmful/unpleasant reactions related to use of medicinal product. Confounder: factor associated with both exposure to drug and outcome of interest. Most clinical studies in phase ii and ii are ra(cid:374)do(cid:373)ised trials (i(cid:374)for(cid:373)ed by what s bee(cid:374) Focused on demonstrating that drug produces expected outcomes in patients and more effective than placebo or active control. Australian regulator: therapeutic goods administration; us regulator: food and drug. Patients not allocated one treatment or another, but simply observed taking treatment they happen to take (unable to assess efficacy of drug) Estimate of treatment effect gained from data of randomised trials. Ic = incidence of endpoint in control; it = incidence in intervention group (assume ic > it) Relative risk reduction (rrr) = 1 - rr.
