ERT develops IVR suicidality monitoring for trials
The last few years has seen a significant increase in regulatory demands for suicidality monitoring in trials with, for example, the US Food and Drug Administration (FDA) introducing it as an absolute requirement in 2008.
This in turn resulted in the creation of methods for assessing suicide risk one of which, the Suicide Severity Rating Scale developed by Kelly Posner at Columbia University, was the basis for ERT’s new system
VP of ePRO solutions Mike Federico told Outsourcing-pharma, that working with Dr Posner, the firm created an interactive voice response version of the CSSRS questionnaire designed to ensure greater consistency during monitoring.
He explained that not only does the IVR approach mean that CSSRS questions are asked in a consistent manner at all trial sites, improving data quality, it also bypasses the difficulties faced by clinical research technicians otherwise in applying such monitoring techniques.
