CNS Clinical Trials Suicidality and Data Collection: Workshop Summary (2010) / Chapter Skim
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Introduction
Introduction
Pages 1-6
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include a prospective assessment for suicidality. 2 Given the focus of the Forum, participants were charged with examining and discussing currently available data, data analysis, and the future of potential partnerships that will be or are being impacted by this announcement as it relates to clinical trials involving the nervous system.
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The FDA required that labeling of specific antidepressants carry black box warnings, intended to alert physicians and patients to increase monitoring of troubling symptoms. One concern at the time was the surge in antidepressant prescriptions by primary care physicians with insufficient oversight of patients (IOM, 2002)
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. At the time of FDA's regulatory actions, in 2004, many public health professionals feared that a black box warning would deter providers from prescribing antidepressants, which in turn could lead to more suicidality from untreated or undertreated depression.
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. Others exclude ideation, thereby defining suicidality more restrictively as an attempt, preparatory acts toward imminent suicidal behavior, or completion.
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clinical trials is to examine what methods are best used to determine treatment emergent suicidal behavior during the conduct of clinical trials. More spe cifically, attendees were asked to: • Review available data on the extent to which emergent suicidal ideation predicts the occurrence, in the short term, of actual suicidal behavior; • Identify promising methods of analysis to address whether suicidal ideation predicts the short-term occurrence of actual suicidal behavior; and • Examine potential partnerships between the Food and Drug Ad ministration, pharmaceutical industry, academia, and the National Institutes of Health that could be used to facilitate data sharing from randomized clinical trials.
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This subtly distinct focus allowed participants to emphasize the importance of capturing suicidal occurrence and non-suicidal occurrence. Elaborating on the specific goal of predicting suicidality, however, Gibbons asked whether suicidal ideation is an appropriate surrogate endpoint for suicidal behaviors and completion.
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