In recent years, treatment emergence suicidality has been on the rise. It has been found in psychiatric and non-psychiatric drugs, among both pediatric and adult trial participants.
In 2003, Paxil was on the FDA’s radar screen based on a report that found an increased risk of suicidality among pediatric patients with a major depressive disorder. In 2005, suicidality signals appeared in 11 antiepileptic drugs. And in 2009, the FDA issued black box warnings to popular smoking cessation drugs.
To help drug and biologic manufacturers deal with potential suicidality in their INDs, the FDA issued a September 2010 draft guidance requiring sponsors to prospectively assess suicidality in their clinical trials. It recommended using two suicide assessment tools.
A team headed by Columbia University Professor Kelly Posner designed the Columbia Classification Algorithm for Suicide Assessment (C-CASA) and the Columbia Suicide Severity Rating Scale (C-SSRS) mentioned in the guidance.
Now FDAnews has invited Dr. Posner to explain how C-CASA and C-SSRS work... and how you can use them in your own clinical trials.
Mark your calendar for Tuesday, Jan. 25, 2011, when Dr. Posner takes the lectern for a 90-minute webinar.
These scales developed by Dr. Posner and team represent best practices for assessing the risk of suicide during clinical trials involving eight types of drugs:
Trial operators administer the C-SSRS by phone (and recently electronically) to assess a trial subject’s possible suicidal thinking and behavior via a series of questions. The C-CASA is used to retrospectively code safety analyses of suicidality data for drugs.
It’s seldom that drugmakers get such an opportunity to interact with a research clinician whose work directly impacts their clinical trial operations. In this session, Dr. Posner will discuss:
Perspectives on the FDA Guidance for Suicidality Monitoring is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you’re at the office or telecommuting from your office-at-home.
The session is totally interactive, so sharpen your pencil and start compiling your questions now. Then, simply submit them via email and Dr. Posner will answer them by the time the 90-minute webinar is over.
Everyone in your organization with a role in suicide assessment will benefit from taking part in this event — and they can do so at a cost that won’t break your budget. You pay a single low registration fee per facility, regardless of how many participate.
So spread the word. Suicide — even the threat of it — can derail a trial completely. Learn how to manage this wild-card risk with these newly-developed best practices. Sign up now.
Kelly Posner Ph.D. 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 to clinical trials of numerous non-psychotropic 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.
The list of those who will benefit from this webinar is a long one, including (but not limited to):