Expert review of clinical pharmacology
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Ethics has often been ignored or evaded in clinical trials, and the conditions under which global clinical trials are conducted make this problem likely to persist. Ethics can, however, have an impact at any of several stages of a trial when the individuals involved are committed. This editorial provides historical examples of ignoring, evading or, alternatively, using ethical help to improve clinical trials, and suggests that the actual role of ethics depends on the individuals involved.
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The role of psychosocial context around patient and therapy can be studied through randomized clinical trials. The analysis of the results of clinical trials, and considering the adverse events (AEs) in the placebo groups, provides an important perspective of study for this phenomenon. In double-blind, randomized clinical trials, the side effects reported in placebo-treated groups are not associated with pharmacological treatment, but other factors should be taken into account to explain these symptoms. ⋯ The authors depicted nocebo effects in antidepressant placebos similar to the AE profiles of the real drugs, which they were matched with. These key findings contrast with the belief that nocebo effects were simply nonspecific. Moreover, they emphasize the need to develop standardized procedures for collecting information about AEs in randomized, double-blind, placebo-controlled trials determining drug efficacy.
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Expert Rev Clin Pharmacol · Jan 2015
EditorialPrediction of treatment outcomes in major depressive disorder.
Improving the treatment of major depressive disorder will require identification of moderators that predict differential outcomes across treatments at the level of the individual patient, referred to as precision medicine. Currently, there are no biological measures demonstrated to enhance treatment selection accuracy although there are some clinical variables that have prognostic value. ⋯ Genetic combination tests, systemic inflammation, electroencephalography and neuroimaging, in particular, show significant potential for near-term development as clinically meaningful moderators for use in treatment selection. Ultimately, combinations of moderators may provide the greatest level of precision in selecting optimal treatment approaches for individual depressed patients.