Current medical research and opinion
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Editorial Comment
Treatment of depression: are we finally on the right track?
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Abstract In January 2011 the American Diabetes Association (ADA) published the latest guidelines for the diagnosis and treatment of diabetes mellitus (DM)(1,2). Despite some controversies, glycated hemoglobin A(1c) (HbA(1c)), an established marker of long-term glycemia traditionally used to assess the quality of DM management, remained an independent criterion for the diagnosis of DM, and indeed now appears to be well established in the USA. This has far-reaching implications for clinical practice worldwide.
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Pain is still one of the most prevalent and distressing symptom in patients with chronic pain. Opioids are the most potent existing analgesics available in clinical practice. However, they are not always effective, particularly in the non-cancer population. ⋯ Several different drug-development strategies have attempted to reduce side effects by exploiting anatomic barriers to drug distribution and to provide different analgesic mechanisms, as in the case of the oxycodone-naloxone combination or tapentadol. New delivery systems have been developed for a more effective management of breakthrough pain. Pharmacogenetics could play a critical role in personalizing pain management in the future.
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Most of the literature on informed consent in pharmaceutical drug research works on the assumption that informed consent is something that is homogeneous and thus can be rendered procedurally universal. This may be justifiable to a certain extent owing to the fact these are all drug trials anyway. Nevertheless, in spite of this general similarity, we also know that the clinical drug development phases are characteristically different, and that phase IV is very different from the other phases because, owing to its postmarketing nature, it is much more varied in scope and in type. ⋯ We shall deal with the issues on the necessity of informed consent for this type of research and then discuss the possibilities for an opt-out system. We conclude that informed consent is necessary for non-interventional studies, and thus any form of waiving of rights of participants to informed consent must have a valid substantial justification. The distinct character of phase IV accounts for the difference in content of the informed consent document compared to that of earlier phases, and both opt-in and opt-out procedures are ethically justifiable as long as the participant's participation remains informed and voluntary.