Institute of Medicine, Board on Health Sciences Policy,'s CNS Clinical Trials: Suicidality and Data Collection: PDF

By Institute of Medicine, Board on Health Sciences Policy, Forum on Neuroscience and Nervous System Disorders, Bruce Altevogt, Miriam Davis, Sarah Hanson

ISBN-10: 0309148839

ISBN-13: 9780309148832

The meals and Drug management (FDA) now calls for that every one scientific trials for medicinal drugs that have an effect on the primary worried system--including psychiatric drugs--are assessed for no matter if that drug may reason suicidal ideation or habit. The Institute of Medicine's (IOM) discussion board on Neuroscience and anxious method problems hosted a gathering on June 26, 2009, to debate the FDA's new coverage and the way to research most sensible no matter if suicidal strategies expect real suicidal habit within the close to destiny.

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Additional info for CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary

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In the case of the meta-analysis supporting the Food and Drug Administration’s (FDA’s) black box warning, the foremost issues are related to the benefits and limitations of a meta-analysis. Several speakers in this session addressed the limitations. They focused primarily on the limitations of metaanalysis as a study design and the multiple alternative explanations for the apparent findings. 25 Copyright © National Academy of Sciences. All rights reserved. html 26 CNS CLINICAL TRIALS: SUICIDALITY AND DATA COLLECTION BOX 3-1 Evidence for Causal Relationships • • • • • Strength of association Dose–response relationship Plausibility: plausible biological mechanism Consistency: replication in different settings using different methods Elimination of alternative explanations for the observed association SOURCE: Hill, 1965.

This clinical trial had several unique features. It studied real-world depression treatments in everyday clinical practice, as opposed to the rarified circumstances of a 35 Copyright © National Academy of Sciences. All rights reserved. html 36 CNS CLINICAL TRIALS: SUICIDALITY AND DATA COLLECTION typical RCT with its strict inclusion and exclusion criteria. RCT patients are typically in better health and have fewer comorbidities than realworld patients. The study sought to find out how patients fared over the long term with depression treatment; its focus was on patients who are hard to treat, considering that the majority of depressed patients do not respond significantly enough to the first antidepressant they try (Little, 2009).

Greenhouse, H. Seltman, and K. Kelleher. 2006. Do antidepressants cause suicidality in children? A Bayesian metaanalysis. Clin Trials 3(2):73–90; discussion 91–98. Copyright © National Academy of Sciences. All rights reserved. html 46 CNS CLINICAL TRIALS: SUICIDALITY AND DATA COLLECTION Keilp, J. , M. A. Oquendo, B. H. Stanley, A. K. Burke, T. B. Cooper, K. M. Malone, and J. J. Mann. 2008. Future suicide attempt and responses to serotonergic challenge. Neuropsychopharmacology online publication March 19.

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CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary by Institute of Medicine, Board on Health Sciences Policy, Forum on Neuroscience and Nervous System Disorders, Bruce Altevogt, Miriam Davis, Sarah Hanson


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