March 9 - POPM*3240 March 9th Randomized Blind Clinical...

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POPM*3240 March 9 th Randomized Blind Clinical Trials - Randomly assign individuals to 2 or more groups o Treatment A, treatment B o No treatment vs treatment - Measure outcomes - Supply statistical analysis Control group is essential! - Allows for comparison - If you give indivudals a treatment and they get better and no comparison – document what goes on but don’t know if they got better because of the treatment or just on their own o Case series - Need some type of comparison – new treatment vs. nothing for e.g. 2 types of controls: Negative control – usually a placebo - Helps us answer the question: does the new treatment work (is it better than nothing) - Placebo looks, smells, tastes like the actual drug but doesn’t have an active ingredient o Meant to trick the individuals into not knowing they are getting the treatment o Easier said than done – trying to mimic a product or medication that may have a unique taste is hard to do But important element - Negative control comparison group is getting the effects Positive control - Helps us determine whether a new treatment is better than the old - Old drug positive control because it has an effect Beware of historical controls - E.g. vaccine literature o When using hisotiral controls – all sorts of things that change year to year that we really have no control over – e.g. challenge may change, environmental conditions, crowding, feed, etc. o If 1984 see all these deaths and then decide to use vaccine next year Looked like vaccine worked o Look a lot different if 1983 we see problem, and then give vaccine next year and deaths double Looked like vaccine didn’t work - Generally a bad idea 1
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How are the groups created? - Goal groups are virtually identical other than the fact that one group will get the treatment and one of them won’t o Want to act to limit confounding variables Randomization – reduces the possibility that unidentified determinants of the outcome will bias the results of the study - Not the same as haphazard -
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