ERT has announced that a survey of more than 250 clinicians has found the Columbia Suicide Severity Rating Scale (C-SSRS) to be an effective method for prospectively monitoring suicidality.
Furthermore, 99 per cent of respondents thought the self-rated eC-SSRS would be an effective approach to meeting this new regulatory requirement.
The eC-SSRS is a self-rated version of the C-SSRS that co-ordinates the patient reported input with the investigators' review.
The poll was conducted during a recent webinar entitled, 'Suicidality Monitoring in Clinical Trials', with presentations provided by collaborators in the development of the eC-SSRS, including Dr Kelly Posner, director of the Center for Suicide Risk Assessment (CSRA) at Columbia University; Dr John Greist, chief executive of Healthcare Technology Systems; and Michael Federico of ERT.
Dr Posner outlined the need for improved and more standardised suicidality monitoring 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 behaviours 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.
