Measuring Suicidality in Clinical Trials - Webinar CD/Transcript

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  The agency issued a draft guidance with updated recommendations, including using the Columbia-Suicide Severity Rating Scale (C-SSRS).

In this special presentation, the chief architect of the C-SSRS will discuss their research, the FDA’s draft guidance and how to use the C-SSRS in multiple research settings.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 The draft guidance states that C-SSRS screening questions should be posed to patients at the start of a study and repeated at every visit either by phone or electronically.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  • How a self-rated approach is part of an optimal response to draft guidance  requirements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.

The list of those who will benefit from this webinar 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

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.