Measuring Suicidality in Clinical Trials - Webinar CD/Transcript
Measuring Suicidality in Clinical Trials: What Your Study Design and Trial Development Teams Need to Know
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. The agency issued a draft guidance with updated recommendations, including using the Columbia-Suicide Severity Rating Scale (C-SSRS).
In this special presentation, the chief architect of the C-SSRS will discuss their research, the FDA’s draft guidance and how to use the C-SSRS in multiple research settings.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 The draft guidance states that C-SSRS screening questions should be posed to patients at the start of a study and repeated at every visit either by phone or electronically.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 research clinicians whose work directly impacts their clinical trial operations. In this session, Dr. Kelly Posner will discuss:
- The best implementation practices and rationale
- How to use the Columbia-Suicide Severity Rating Scale (C-SSRS) to determine the SIB categories
- How a self-rated approach is part of an optimal response to draft guidance requirements
- How to reduce site and sponsor burden while providing predictive capability
- Operational factors to be considered when capturing the important information
- And much more
Learn how to manage this wild-card risk with these best practices.