Suicidality Monitoring in Clinical Trials

ERT announces that a recent survey of over 250 respondents reported that all clinicians polled found the Columbia Suicide Severity Rating Scale (C-SSRS) to be an effective method for prospectively monitoring suicidality. Furthermore, 99% of respondents thought the self-rated eC-SSRS would be an effective approach to meeting this new regulatory requirement. The eC-SSRS is a pioneering self-rated version of the C-SSRS that coordinates the patient reported input with the investigators’ review. These findings are supported by users of the eC-SSRS.

The poll was conducted during a recent webinar entitled, ‘Suicidality Monitoring in Clinical Trials’, with presentations provided by collaborators in the development of the eCSSRS. The need for improved and more standardised suicidality monitoring was highlighted and the advantages of the C-SSRS verses only documenting spontaneous adverse events. The C-SSRS has been identified by the FDA as an acceptable assessment instrument for prospectively monitoring suicidal behaviors in clinical trials. The webinar also highlighted that a more consistent and systematic assessment, such as eC-SSRS combined with clinician review, would more clearly delineate the relationship between suicidal adverse events and medication treatment with more meaningful data within a study, as well as across

studies, improving pooled analyses.

ERT’s eC-SSRS solution provides customers with a scientifically sound, cost-effective and convenient method of prospectively monitoring for suicidality and has been

designed in line with FDA requirements. Data was presented from the successful eC-SSRS validation study sponsored by a major pharmaceutical company with results demonstrating high levels of feasibility, reliability and validity for assessing suicidality and protecting patient safety. Many large and mid-size pharmaceutical companies are choosing to implement the eC-SSRS solution.

Using this approach can also lessen site burden and reduce sponsor costs by as much as 45%. The results of the webinar poll indicated that 97% of study managers thought that using the coordinated self-rated eC-SSRS verses a clinician-only administered approach could reduce their cost.