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On June 16th, 2009, the IOM Forum on Neuroscience and Nervous System Disorders held a workshop on CNS Clinical Trials: Suicidality and Data Collection.
Purpose and Objectives of the Workshop:
An ad hoc committee planned and hosted a public workshop inviting individuals from the FDA, pharmaceutical industry, academia, NIH, and advocacy groups to make presentations and stimulate discussions focused on how best to integrate the current tools for data collection with current methods of data analysis. In addition, the workshop participants discussed opportunities for potential partnerships with various stakeholders. Specifically, participants were invited to present and discuss information that will:
- Review available data on the extent to which emergent suicidal ideation predicts the occurrence of actual suicidal behavior particularly in the short-term.
- Ascertain optimal methods of analysis to address if suicidal ideation predicts the short-term occurrence of actual suicidal behavior.
- Examine potential partnerships between the FDA, pharmaceutical industry, academia, and the NIH that could be used to facilitate data-sharing from randomized clinical trials.
Workshop Summary:
A workshop summary will be prepared that will be subject to appropriate review procedures before release and will serve to inform the Forum's future meetings.
Workshop Planning Committee:
An ad hoc planning committee was appointed by the IOM to organize the workshop. It includes representatives from the Forum on Neuroscience and Nervous System Disorders and other key stakeholders to assist in the organization and planning of this event.
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