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dfishervan's picture

Control Groups

      I must admit that I may be biased when it comes to commenting on clinical trials since the two trials I have assisted on have turned out to be incredibly successful and have worked mostly with elderly study subjects who had more time available to participate in the study. That being said, I do not believe clinical trials as a whole are unethical although there are some ethical questions associated with conducting a clinical trial.

Concerning the issue control groups, I do not find their existence unethical unless the study drug/procedure shows immense improvement over the current form of treatment, in which case the study would be stopped. I must admit that my initial reaction to control groups was negative and I wondered the same things Hope mentioned in class. I wondered why a control group was necessary if we most likely had data on how patients responded to a drug that had been used for decades. However, you must remember that I was working on a study that had very positive results. In clinical trials, the possibility of ending up in a control group is a risk that the study subject is aware of when enrolling in a study. In cases where the study drug shows no improvement over or proves to be worse than the traditional treatment, we do not question whether control groups are ethical and certain study subjects will be glad that they ended up in a control group. Also, we must remember that upon enrolling in a clinical trial, the subject’s individual health is prioritized over the study. If members of a control group in a successful clinical trial wish to withdraw and receive traditional care provided to any other person with that illness, they have that option at anytime. The drug being tested in clinical studies is not available to the public so regardless of whether or not the control group patient drops out of the study, he/she will still not have access to the drug. Of course, there are instances where doctors can appeal the IRB and request that patients receive a study drug that has tested positively and reached a certain study phase as a last resort. 

 

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