ERT, a provider of patient safety solutions, has upgraded its electronic suicide risk assessment system AVERT to identify the occurrence of suicidal thoughts and actions among patients during clinical trials.
Currently available in audio and visual patient interfaces, which provide greater flexibility to biopharmaceutical firms, the system has already been used by more than 32,000 patients in clinical trials and has captured more than 100,000 assessments.
Forest Research Institute clinical development senior director Carl Gommoll said it is critical 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 (SIB).
In 2012, the US FDA revised the Draft Guidance for Prospective Assessment of SIB in psychiatric and non-psychiatric trials, according to which researchers should develop and follow study protocols that assess SIB risks in patients and enable them to rectify their behavioral health.
Based on this idea, AVERT offers electronic administration of suicide risk assessment questionnaires, which are scientifically proven and kept brief for the benefit of patients.
During investigative site visits, patients enrolled into clinical trials can quickly answer the SIB-related interview.
If the interview identifies an at-risk patient, AVERT immediately alerts the investigative site to take corrective measures based on the protocol.
AVERT's application is delivered through an electronic patient self-rated version of the Columbia Suicide Severity Rating Scale (eC-SSRS), which has been approved by the FDA for assessing SIB.
Moreover, the system's patient self-rated interviews offer more reliable data than those generated by traditional interviews administered by clinicians, as there is lesser risk of non-disclosure by patients and variability of assessors.
Following a scientific collaboration with C-SSRS author Dr. Kelly Posner and psychiatrist Dr. John Greist, ERT has improved the application in order to identify the recency of suicidal thoughts and actions.
The enhanced system draws the investigative site's attention to troubled responses from patients, with regard to any recent events, and if such responses need a follow-up by a mental health professional.
ERT CEO Dr Jeffrey Litwin noted that the company is offering 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," Litwin added.