Risk of Prospective Suicidal Behavior Reports among Psychiatric and non-Psychiatric Patients using Lifetime Reports at Baseline - By Dr. James Mundt et al
Description
International Society for CNS Trials and Methodology Presented Poster, February 2013 - Baseline reports of a lifetime history with suicidal ideation with an intention to act, prior suicidal behaviors, or both, significantly increase patient risk for prospectively reporting suicidal behavior during study participation. Reports of such are higher among psychiatric patients; however, the increased risk conveyed by the lifetime assessments also generalizes to non-psychiatric patients.
DownloadElectronic Assessment of Suicidal Ideation and Behavior for Meta-Analyses across Multiple Trials and Treatment Indications - By Dr. John Greist et al
Description
International Society for CNS Trials and Methodology Presented Poster, February 2013 - Neurologic and non-CNS studies found similar prevalence rates of SIB using the eC-SSRS at baseline and prospectively during study participation. These rates were substantially less than the suicidal ideation and behavior rates self-reported by psychiatric patients. Although less frequent, positive findings were a substantial safety concern in these non-psychiatric trials.
DownloadIdentification of Cardinal Symptoms in Patients with Chronic Idiopathic Constipation - By A. Joslyn, L. Barrow, J. Paty
Description
Digestive Disease Week, May 2012 - This poster reviews the process Synergy Pharmaceuticals went through in developing an instrument to collect daily Patient Reported Outcomes (PRO) data from CIC patients. [formerly an invivodata resource]
DownloadMeasurement in Clinical Trials: Review and Qualification of Clinical Outcome Assessments - By FDA
Description
FDA Public Workshop, October 2011 - The FDA hosted a workshop that will change how developers of medical products select, evaluate, and provide evidence to support endpoints for their clinical development programs. [formerly an invivodata resource]
DownloadeC-SSRS Assessments of Lifetime Ideation and Behavior are Predictive of Suicidal Behaviors Occurring During Trial Participation
Description
International Society for CNS Trials and Methodology Presented Poster, October 2011 - Safety concerns regarding suicidality in clinical trials resulted in the release of FDA draft guidance in September, 2010.
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