The ethical position of the attending physician in Phase III of clinical investigations.
The ethical position of the attending physician in Phase III of a clinical trial differs from his position in the other two phases. In Phase II he normally presupposes that the new drug has a priority as regards one or more therapeutic properties compared with the already known drug, which he uses as the control. Phase III is based on the results of the Phase II investigations; thus the drug has been proven to be effective therapeutically before Phase III begins. The patients have to be informed about the properties of the drug to be tested. The position of the physician informing them is explained and discussed with respect to the differences between the new and the old drug.
D002986:Clinical Trials as Topic; D035061:Control Groups; D030881:Disclosure; D004992:Ethics, Medical; D005860:Germany, West; D006801:Humans; D033281:Nontherapeutic Human Experimentation; D018579:Patient Selection; D010820:Physicians; D011897:Random Allocation; D035842:Research Subjects; D018570:Risk Assessment; D036302:Therapeutic Human Experimentation; D014342:Truth Disclosure