Placebo Arm Case Studies

usually compared to the best standard of care. It must be pointed out that in oncology patient population, placebo arm is not explicitly needed like in psychiatric clinical trials where placebo effect is significant problem. In oncology clinical trials, placebo arm is not considered as ethical, due to severity of the disease and life-threatening condition, so scientific curiosity can not prevail over the best interest of individual patient. In clinical trials investigating add on treatments, it is usually add on to the standard of care treatment in comparison to placebo. There is still open question should sponsor provide for free background therapy. In this case it could also be considered as investigational drug, but is usually not expected

Placebo effect coming from patient 's expectations and more physician attention can not be justified in patient population with life threatening diseases. It is difficult to find more benefits for patients that could prevail over risks of being left untreated with metastatic breast cancer if in placebo arm. Even the option of not being treated at all, being left at home, and not being given any medical care, is more acceptable, because at least patients will not be exposed to sometimes difficult transportation to hospital for study visits and various diagnostic tests. It is expected that they are very weak, easily fatigued and that they will not be able to perform even the simple activities of daily living. It is really difficult to justify all this nuisance of study visits without any benefit for an individual patient that is in such a difficult health condition. One can only think of maybe decreasing the level of depression by engaging with other patients in waiting

(Wanderpool, 1996). Without validity the research can not generate any relevant new knowledge and risks of exposing subjects to potential known and unknown risks can not be justified. (Emanuel et al., 2000). Development of new treatment algorithms is relevant scientific goal and already existing knowledge and guidelines can and must be challenged, since this is the condition for science to be progressive. However, potential risks and benefits of new treatments must be fairly distributed. What is too risky for subjects from developed countries, can not be acceptable for subjects coming from developing countries. Those who should enjoy benefits, should share some risks, and those who are taking risks accepting to be included in testing new treatments must be in position to bear some benefits. (Emanuel et al. 2000). Nuffield report suggest that even though a universal standard of care cannot be provided to participants this research should still be conducted because it might help to develop responses to health care needs in developing countries. While we agree with the report’s view about this research it is worth considering whether the reasons they give are adequate and justifiable (McMillan et al. 2004). While some studies can be justified as in the case of "the research on HIV in sub-Saharan Africa that can be justified by the