FDA-adopted Columbia-Suicide Severity Rating Scale (C-SSRS) Categories for Prospective Assessment Improving Precision of Identification and S
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Suicidality — or even the hint of it — can derail a trial.
The FDA is concerned about suicidal thoughts and behaviors arising from — or compounded by — the use of investigational new drugs in clinical trials. In August, the agency issued a draft guidance with updated recommendations, including using the Columbia-Suicide Severity Rating Scale (C-SSRS). These improved data collection methods are of critical importance, as debunking false notions of risk and accurately identifying true risk are equally crucial from a public health perspective.
In this audio CD/Transcript, the development team for the C-SSRS will discuss their research, the FDA’s draft guidance and its implication and how to use the C-SSRS in multiple research settings.
The FDA recommends proactive assessments of suicidal thought and behavior for any drug being developed for a psychiatric condition, for antiepileptic drugs and for other neurologic drugs with central nervous system activity. The new draft guidance states that C-SSRS screening questions should be posed to patients at the start of a study and repeated at every visit either by phone or electronically.
It’s seldom that drugmakers get such an opportunity to interact with the developers of the FDA guidance commissioned (Dr. Posner led the team commissioned by the FDA) and recommended methods. In this session, Dr. Posner, Dr. Greist and Mr. Federico will discuss:
- The FDA’s revision and rationale for the 2012 draft guidance and best implementation practices
- Clarify the Columbia-Suicide Severity Rating Scale (C-SSRS) 11 categories required by the guidance
- How a self-rated approach is part of an optimal response to draft guidance requirements
- How use of the C-SSRS reduces site and sponsor burden while providing predictive capability, and protecting compounds against the potential of false signals
- Optimal models of sponsor and study implementation guidance and policies will be reviewed