The clinical trial study design involves a study group that is exposed to the ne

Question

The clinical trial study design involves a study group that is exposed to the new treatment and a control group that receives either the usual, standard treatment or a placebo. A placebo is designed to look just like the new treatment but it doesn't have any active or effective component.

What steps should be taken in conducting clinical trials to insure patient safety and to make sure that patients are informed about the use of a placebo in the study before they consent to be part of the study?

Explanation / Answer

Placebo study involves administration of a sugar pill or inactive ingredient. Placebo studies are rquired to check the results of active drug are unbiased. The placebo trials generally, not revealed to patients and the symptoms and betterments resulted are closely monitored. If the studies involve a drug testing against some types of cancers, patients should be revelaed about placebo study. In these studies, generally the placebo does not show any affect on cancer disease. When the active treatments or drugs are available for any sort of disease, using placebo studies would be unethical. Hence, it is very important to take the patient consent about a placebo study.

In new drugs testing, generally standard drug and placebo are used on one group and drug under testing on another group, but only placebo studies are not conductued on either group. Patients are explained with results of pre clinical trials conducted on cell cultures and animals and finally, convince them and to take their consent about placebo studies is most important and are strictly followed by clinical trial studies all over the world, since, it is law framed by FDA.

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