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Lecture 7

CHSC 4P99 Lecture 7: Therapeutic Trials I.pdf

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Brock University
Health Sciences
Brent Faught

Therapeutic Trials I March-03-15 2:00 PM How an idea become a hypothesis (Serendipity) • Molecular evidence (penicillin) • Clinical observations (peppermint and colic) • Trial and error (tamoxiphan prevents breast cancer in the other breast) • Epidemiological evidence (fluoride and water, red wine a CVD) Treatment effects • Observation study ○ Advantages: cheap ○ Disadvantage: so many outside variables that influence results (systematic bias) (type 1 error, alpha error) • Clinical trial ○ Advantages: control environment, decrease alpha error ○ Disadvantage: expensive • We allow only 5% error for alpha, and 15% error for beta error Randomized control studies • Why do we randomize? ○ To control for experimental bias Sampling • Important subjects reflect patients who get the diseases • Reasons these patents may not be included ○ Don't meet inclusion criteria ○ Refuse participation ○ Don't cooperate with conduct of clinical trial Intervention • Distinguishesthe difference between population epidemiology and clinical epidemiology • Generalizability (not external validity) ○ Whether the intervention reflects standard therapy  Most cases are, but some aren't  As long as we can justify it, it's pretty cool • Complexity ○ Most are simple(drug versus no drug) ○ Aliments that have multiple forms of therapy  Heart disease • Strength ○ How powerful is the treatment Example: thyroid surgery works 95% of the time, lumbar perfusion surgery <3% of time ○ Example: thyroid surgery works 95% of the time, lumbar perfusion surgery <3% of time Comparison Groups No control Observation •Gives the total effect of the drug •No control group •Includes the placebo effect •Problematic when the participants know they are being
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