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Course Notes - Department of Mathematics and Statistics

Course Notes - Department of Mathematics and Statistics

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B. R<strong>and</strong>omised control - <strong>of</strong> all children who had parental consent,half were r<strong>and</strong>omly allocated to the control group <strong>and</strong> theother half vaccinated.- The control group were “vaccinated” with a saline solution- Children, Drs, researchers didn’t know which child was inwhich group until after the experiment.Polio vaccine trial IIIDesign Trt group n Cases Rate (per 100,000)Observed Control Vaccinated 221998 56 25.2Observed Control Controls 725173 391 53.9R<strong>and</strong>omised Control Vaccinated 200745 57 28.4R<strong>and</strong>omised Control Placebo 201229 142 70.6• Observed control design biased against the vaccine.- Confounding <strong>of</strong> vaccine effect <strong>and</strong> ‘parental consent’ effect.- Children from poorer families had a natural level <strong>of</strong> immunity<strong>and</strong> less likely to receive consent for involvement in the trial.Chance effect or real?• Just by chance things almost always differ. Could this be chance?• Suppose we have two unfair coins, a ‘Control’ coin <strong>and</strong> a ‘Vaccine’coin• We toss the control coin 201,229 times <strong>and</strong> the other one 200,645times.• If they had the same chance <strong>of</strong> coming up heads what is theprobability <strong>of</strong> observing the outcome 142 heads for the controlcoin <strong>and</strong> 57 for the vaccine coin, or a more extreme one?- More than one billion to one against- Coins are not the same.25

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