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, a leading global solution provider for high-quality patient safety and efficacy endpoint data collection, today announced enhancements to AVERT™, its proven electronic suicide risk assessment system. Having already been 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.
Having captured over 100,000 assessments to date, AVERT is a proven and reliable tool for biopharmaceutical developers who need to assess for suicide risk during clinical development programs. Carl Gommoll, Sr. Director Clinical Development at Forest Research Institute stated, “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. 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 As a result of this safety risk, in 2012 the U.S. FDA issued a revised Draft Guidance for Prospective Assessment of SIB in psychiatric and non-psychiatric trials.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. By using AVERT, clinical trial patients can comfortably and confidentially 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 passionate about finding ways to help researchers protect their patients, and their new products in development,” said Jeffrey Litwin, M.D., CEO of ERT. “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. By combining leading technology with good science we can continue to help improve clinical research and improve patient safety.”
AVERT’s patient self-rated interviews deliver more reliable data than traditional clinician administered interviews by reducing the risk of patient non-disclosure and assessor variability. Continuing its scientific collaboration with C-SSRS author Dr. Kelly Posner and leading industry psychiatrist, Dr. John Greist, ERT has enhanced the application to identify the recency of suicidal thoughts and actions. This system enhancement focuses the investigative site’s attention on any troubling responses regarding recent events that require follow-up by a mental health professional.
Overall, investigative sites benefit from these complete, consistent assessments and reporting, as well as from reduced staff burden. By utilizing AVERT, clinical trial sponsors gain greater visibility into patient safety and increased confidence in meeting the FDA guidance on SIB. The resulting reliable and high-quality data allows sponsors and regulators to document the drug’s true effect on suicidal ideation and behaviors.
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