March 7 - POPM*3240 March 7th 2016 Randomized Blind...

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POPM*3240 March 7 th , 2016 Randomized Blind Clinical Trials Thalomid – most effective drugs in treatment of things like leprosy - One of the examples that at the time and since the late 50’s has contributed to our rethinking about how we approve drugs for use in humans and animals - Very strict regulations about what we can and cannot use - Regulations and approval processes – based on two fundamental issues: o Safety o Efficacy – does it work? does it do what it says it does? Medical/Veterinary Questions How do we know which treatment is better? - Tylenol vs. herbal How do we know whether a vaccine works? - Flu vaccine vs. no vaccine How could you answer these? - About comparison o Prescribe a drug and see how it affects people o Placebo Observational Study: COHORT - 2 or more groups – already exist - We watch these groups and count new cases - Advantages: o Don’t need to get ethical approval o With clinical trials, there are some ethical considerations to take note of Intervention Study: Randomized Clinical Trial - 2 or more groups – we create them o Formal process randomization - We follow the groups and count new cases - Assign individuals to treatment or intervention groups o Can potentially give us information that is a lot more useful Field experiments – take place outside in the real world - Something we strive for - But can be expensive and can be difficult Clinical trials Start with a hypothesis – question we want to answer
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