Suicidality: How to Ensure Quality in Mandated Prospective Monitoring

Since the discovery that some medications may be associated with increased suicidal ideas and acts (suicidality), the need to identify these adverse events has been recognised by FDA.

Initially concern focused on psychiatric drugs for psychiatric disorders where suicidal thinking and attempts are recognised. However, some non-psychiatric drugs have also increased suicidal thoughts and acts in people without psychiatric disorders.  These conclusions were reached from Meta analyses of retrospective data laboriously culled from case report forms of randomised controlled trials. One firm conclusion from this effort was the need for prospective evaluations in new drug evaluation of relevant compounds to improve data quality and timeliness.

In September 2010, FDA released its Draft Guidance on Suicidality: Prospective Assessment of Occurrence in Clinical Trials. The guidance advocates prospective assessment for suicidality to identify patients at risk and collect complete, timely data in:

• All psychiatric indications at baseline and all subsequent visits
• All neurology compounds with CNS activity
• All other drugs similar to drugs about which there has been concern 

This requirement places a burden on all involved in drug development, sponsors, sites and patients. A burden which is justified to protect patients in clinical trials and to ensure accurate identification and measurement of risk, including an absence of risk.

Developed by experts from several institutions and used over the past seven years, the Columbia-Suicide Severity Rating Scale (C-SSRS) is the recognised gold standard prospective assessment for suicidality. C-SSRS use requires training and comfort in addressing this sensitive clinical issue.

After development and validation, eC-SSRS (a computer administered version of C-SSRS) has been used for the past year in nearly 20,000 assessments. eC-SSRS employs the authors’ exact wording and faithfully follows the C-SSRS algorithm, documenting each question and response. A report is generated immediately after completion and telephone alerts are also made with study sites for positive reports to enhance further clinician evaluation.

This Webinar will review:

• The need for suicidality monitoring
• Describe C-SSRS and eC-SSRS
• Present descriptive data from eC-SSRS assessments through Nov 30, 2010
• Cover site considerations in use of C-SSRS and eC-SSRS

Presenters:

Dr. John Greist
Distinguished Senior Scientist
Madison Institute of Medicine