Prospective suicide risk assessment is used to measure lifetime suicidal ideation and behavior (SIB) to provide a baseline and insight into the prospective risk for future suicidal behavior, as well as a means for ongoing monitoring. AVERT™ is ERT’s electronic suicide risk assessment system that provides simple audio (phone) or visual (web or tablet) solutions that are efficiently and effectively implemented in any clinical study.
PROTECTING PATIENTS. PROTECTING COMPOUNDS.
The risk of suicidal ideation and behavior is very real and, unfortunately, increasingly common. According to the CDC, suicide was the tenth leading cause of death in the United States in 2010 (the latest year recorded). This increased prevalence of SIB also increases the risk that a patient will exhibit increased suicidal ideation and behavior and – in the very worst cases – commit suicide while taking part in a clinical trial.
The FDA guidance recommends that SIB monitoring is performed at every study visit, including unscheduled visits, during all trials involving compounds falling under the remit of this guidance. Monitoring is to include a baseline (or lifetime) assessment of all patients when they are first entered into a study. This monitoring then continues at subsequent visits where patients are asked whether there have been any changes in SIB since their last assessment. This allows sponsors to monitor any changes in SIB from initial assessment and between visits. Any scale used to monitor SIB should directly map to and populate the 11 SIB (formerly C-CASA) categories.
When developing new drugs in particular indications and therapeutic areas, there is a risk of treatment-emergent Suicidal Ideation and Behavior (SIB) in clinical trial patients. To address this risk, in August 2012, the FDA issued a revised Draft Guidance on the Prospective Assessment of SIB in Clinical Trials. The guidance highlights the responsibility of study sponsors to ensure the safety of patients in psychiatric and non-psychiatric drug trials falling under the authority of the FDA.