Although it is likely that initiate a detailed investigation and prompted the unresolved issue of Clinical Practice previously not covered in the available literature. In addition to this, the reason for initiating a detailed study is quite often unexpectedly received antitumor effect of therapy, which is designated "out of desperation." Following the data is usually generated by a detailed study plan, which is an intention to treat some patients and see what this will turn out. Probably more than that at the beginning detailed study of the image and likeness of international studies are the criteria for inclusion, exclusion, treatment plan (but not so rigid or overly binding further performance – we did not West, auditors do not have). Control group, randomization – why? If we manage to get enough from our point of view, the effect can be selected comparison group of those whom we treated earlier. Teva recognizes the significance of this. How many include patients? Well 20 people (Versions 15, 30). Why? Round number looks familiar (in the past study also had 15, 20, 30), about the patients is taking place in our heart for the month (six months per year).
In addition to this, it is quite possible restriction on the number the drug (although this would have given). Informed consent? Yes this is almost a standard method – write about it in two foreign papers (option: According to patients still have nothing to lose, and we offer them treatment). What is the phase research? Once the drug was used before, so obviously not the first.
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