Wednesday, 5 January 2011

Facilitating compliance with FDA guidance on suicidality assessment in clinical trials

ERT, a global provider of technology and services to the pharmaceutical, biotechnology and medical device industries, announced that its eC-SSRS (Electronic Columbia Suicide Severity Rating Scale) solution facilitates compliance with the newly introduced Food and Drug Administration (FDA) guidance document entitled "Suicidality: Prospective Assessment of Occurrence in Clinical Trials." A copy of this guidance can be downloaded from

The recently released FDA guidance document is intended to assist sponsors in assessing the occurrence of treatment-related suicidality in clinical trials or drug and biological products. The guidance highlights the increasingly recognized importance of suicidality assessment in psychiatric and non-psychiatric drug trials and provides general principles for how best to achieve effective assessment during the drug development process. The document highlights the Columbia Suicide Severity Rating Scale (C-SSRS), which comprises a detailed interview as an approved assessment instrument.

The guidance intends to serve as a focus for continued discussions among the FDA, pharmaceutical sponsors, the academic community and the public.

ERT's eC-SSRS is an electronic self-rated version of the C-SSRS, which was developed in collaboration with the scale authors and provides a cost-effective method of proactively monitoring suicidality for trial sponsors. The solution was designed in anticipation of the FDA recommendations outlined in the newly released guidance document. Using interactive voice-response technology validated against the C-SSRS, the eC-SSRS is a fully structured interview providing standardized questions,  relevant follow-up questions, error-handling routines and scoring conventions. Helping to facilitate the FDA requirements, the eC-SSRS solution enables timely identification of possible risks and supplies rapid feedback to study sites for evaluation and follow-up.

Michael Federico, Vice President, ePRO, comments: "The release of the FDA document highlights the growing focus on treatment-related suicidality and the need to develop an accurate and effective method for use in clinical trials to enhance effective patient-safety monitoring. Bearing in mind the concerns regarding the burdens placed on investigators, ERT has created the eC-SSRS, a validated representation of the interview version C-SSRS, which facilitates the ability to reliably and reproducibly assess suicidality and comply with FDA guidance."