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PHL283H5 (40)
Lecture

PHL283 Mar 3 2011

3 Pages
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Department
Philosophy
Course Code
PHL283H5
Professor
Jonathan Peterson

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Description
PHL283 March 3 rd - clinical research on medical subjects - randomized controlled clinical trials o certain goal – something whether a particular intervention/treatment is effective and safe – side effects etc. – compare to others – what is safer? o in order to do that, you need to start testing on humans o what is a controlled trial?  control the variables to see the effect of one or two  minimize possibility of bias - don’t want anything to affect the outcome of the study  divide into 2 groups • experimental group – give them the drug • controlled group – not give them the drug • compare the results to eliminate the bias and possible factors that might affect the outcome - control groups: o placebo control trials: can do a trial when the controlled group is given a placebo – control psychological effects o active control trial – don’t give them a placebo, but give them an alternative treatment  experimental get the new, control get the old – compare results - randomize – to prevent more bias o have to randomly assign the participants into each group o ensure the studies are “blind” – don’t want people to know which group they’re in – experimental or controlled o want the study to be “double-blind” – both the researcher and participant should not know who is in which group – to eliminate any bias that may result - is it permissible to have a placebo controlled trial? o are permissible but only under certain circumstances Declaration of Helsinki - in the normal case, you should run an active control trial o already some accepted drug for the illness, they should get that one  best available treatment - standard of care – best available treatment – obligation to provide – should give that to the controlled group - compare the experimental with the standard of care - it’s okay to use placebo when there is no proven therapy out there for the condition - some participants will get no benefit from the study – ie. the placebo group - if assigned to the experimental group – could be worse effects in terms of the new drug - issue of carrying out research that will have no benefit to carrying out research 1. Is it ethical for a physician to recommend participation in a randomized controlled clinical trial? - what is the challenge? what is the problem with suggestion? Hellman and Hellman - obligation of a physician – to provide the best treatment available to the patient o role – tied in the relationship with the individual patient o fundamental obligation is to act in the best interest of the patient – central obligation  fidelity – faithfulness to the patient  Kantianism - obligation of a researcher – benefit humanity as a whole – utilitarianism o utilitarianism – maximizes happiness for everyone – but can be in the expense of one person – to benefit humanity in general o utilitarianism to Kantianism  not treating people as a means – treat people as an end in themselves  you owe people a certain kind of respect  worried about making sure we don’t do harm to others to benefit people o not sure where the physician’s obligations come from  special relationships = special duties (physician-patient relationship)  however, researchers don’t have special relationships – but they should also treat people properly o can utilitarianism allow for special relationships? - if you as a physician suggest a patient to enrol in a trial, you are violating your duty as a physician because you are always supposed to give/suggest the best treatment (standard of care) o don’t even know what group they will end up in – one can be toxic/better than the other o may be setting up your
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