ERT, a global solution provider for patient safety and efficacy endpoint data collection, has announced enhancements to AVERT, its electronic suicide risk assessment system. Having captured over 100,000 assessments to date, AVERT is a tool for biopharmaceutical developers who need to assess for suicide risk during clinical development programs.
After being used by over 32,000 clinical trial patients, AVERT is now available in both audio (phone) and visual (web/tablet) patient interfaces, offering greater flexibility to developers of new biopharmaceutical products.
“It is critical for us to understand the complete safety profile of new drugs in development, especially if during the course of a trial patients experience suicidal ideation and behaviors,” said Carl Gommoll, senior director of clinical development at Forest Research Institute. “By administering AVERT we feel we are taking the most comprehensive and effective approach to identify the emergence of suicidal ideation and behaviors in order to enhance patient safety, which is our highest priority.”
Biopharmaceutical developers face the risk of treatment-emergent suicidal ideation and behavior (SIB) occurrence among patients in clinical trials. As a result of this safety risk, in 2012 the FDA issued a revised Draft Guidance for Prospective Assessment of SIB in psychiatric and non-psychiatric trials. The guidance requires researchers in high-potential SIB risk areas to develop and follow study protocols that proactively assess SIB risk and enable proper behavioral health treatment for at-risk patients.
AVERT presents electronic administration of scientifically proven suicide risk assessment questionnaires. Its current application is delivered through an electronic patient self-rated version of the Columbia Suicide Severity Rating Scale (eC-SSRS), which is cited in the FDA guidance as an acceptable instrument for assessing SIB. Using AVERT, clinical trial patients can respond to a brief, SIB-related interview during investigative site visits or from home. If AVERT identifies an at-risk patient, the investigative site is alerted immediately, enabling them to take appropriate action per the protocol.
“We are pleased to offer an enhanced version of AVERT that can be administered in a mode most comfortable for the patient, making the assessment of SIB risk more efficient and reliable for biopharmaceutical developers,” said Jeffrey Litwin, M.D., chief executive officer of ERT.