FDA-adopted Columbia-Suicide Severity Rating Scale (C-SSRS) Categories for Prospective Assessment Improving Precision of Identification and Safety Monitoring, Optimizing Data Collection While Avoiding False Signals and Decreasing Burden

Held Oct. 25, 2012

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  In August, the agency issued a draft guidance with updated recommendations, including using the Columbia-Suicide Severity Rating Scale (C-SSRS).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.

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In this audio CD/Transcript, the development team for the C-SSRS will discuss their research, the FDA’s draft guidance and its implication and how to use the C-SSRS in multiple research settings.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 The new draft guidance states that C-SSRS screening questions should be posed to patients at the start of a study and repeated at every visit either by phone or electronically.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  • The FDA’s revision and rationale for the 2012 draft guidance and best implementation practices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  • How a self-rated approach is part of an optimal response to draft guidance requirements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

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The list of those who will benefit from this audio CD/Transcript is a long one, including (but not limited to):

  • Clinical project specialists
  • Clinical research associates
  • Clinical trial committees
  • Consultants/ service providers
  • Executive management
  • Investigators
  • R&D staff
  • Regulatory/ legislative affairs professionals
  • Risk management specialists
  • Study sponsors
  • Medical affairs
  • Scientific affairs
  • Directors of drug development programs
  • Project managers
  • Biostatistics staff and managers

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Dr. Kelly Posner founded the Center for Suicide Risk Assessment at Columbia University/New York State Psychiatric Institute. She led a team that developed methods of suicidality assessment and fostered interpretability of data. The methodology that emerged – the Columbia Classification Algorithm of Suicide Assessment (C-CASA) – has been recommended for clinical trials of numerous nonpsychotropic drug classes and centrally acting agents. The FDA has said this work “[sets] a standard in the field.” Dr. Posner continues to work with the FDA and other federal agencies on suicide assessment, surveillance and prevention, and publishes and speaks internationally on the risks, benefits, and public health implications of drug safety controversies.

Dr. John Greist is a Distinguished Senior Scientist at the Madison Institute of Medicine, Clinical Professor of Psychiatry at the University of Wisconsin School of Medicine and Public Health, and the CEO of Healthcare Technology Systems. He is also the co-Founder of the Lithium Information Center, Bipolar Disorders Treatment Information Center and the Obsessive Compulsive Information Center at the Madison Institute of Medicine. His major clinical and research interests are anxiety and mood disorders, psychopharmacology, behavior therapy, and clinical applications of computing. In addition to more than 300 articles in professional journals and chapters in books, he has coauthored many books and has lectured nationally.

Michael Federico is the Vice President of ePRO solutions, ERT Inc. Michael is responsible for managing all aspects of the ePRO Solutions suite at ERT, including product development, operations and sales. The ePRO group has organized ERT’s capabilities into products and services to provide the complete patient experience from recruiting right through to suicidality monitoring. Prior to his current position, Michael was VP for Business Development at ERT. Prior to joining ERT six years ago, Michael spent over 20 years in systems design, evaluation and equipment management in the healthcare field.

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