PHILADELPHIA, PA – September 30, 2013 –– ERT, a leading global solution provider for high-quality patient safety and efficacy endpoint data collection, today announced that the Journal of Clinical Psychiatry (JCP) has published a paper demonstrating the effectiveness of the electronic, patient-reported version of the Columbia Suicide Severity Rating Scale – also known as the eC-SSRS – in assessing suicide risk among clinical trial participants. “Prediction of Suicidal Behavior in Clinical Research by Lifetime Suicidal Ideation and Behavior Ascertained by the Electronic Columbia-Suicide Severity Rating Scale,” published September 2013 verifies that the eC-SSRS can help biopharmaceutical developers proactively assess for risk of suicidal ideation and behavior (SIB) in order to protect trial patients and ensure accurate SIB data related to new drug compounds. This version of the Columbia Scale is accepted by the FDA and is the instrument currently at the core of AVERT™, ERT’s suicide risk assessment solution.
The peer-reviewed paper presents results from over 35,000 eC-SSRS assessments collected among clinical trial participants. It evaluates whether lifetime suicidal ideation with intention to act and/or suicidal behaviors reported directly by the patient at baseline predict risk of prospectively reporting suicidal behavior during subsequent study participation.
“The most important finding of the study is the predictive relationship between lifetime suicidal ideation and behaviors, reported at study baseline, and the risk of prospectively reporting suicidal behavior during subsequent study participation,” said Dr. Jim Mundt of the Center for Telepsychology, who authored the paper. “Even with the relatively short mean follow-up period, of about 9 weeks, patients reporting lifetime ideation with an intention to act, prior suicidal behaviors, or both at baseline were roughly 4 to 9 times more likely to report suicidal behavior during a study follow-up visit than patients who reported no lifetime ideation with intent to act or prior behavior.”
Biopharmaceutical developers face the risk of treatment-emergent 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 As a result of this safety risk, in 2012 the U.S. FDA issued a revised Draft Guidance for Prospective Assessment of suicide risk in psychiatric and non-psychiatric trials.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 suicide risk and enable proper behavioral health treatment for at-risk patients.
ERT’s AVERT is a proven and reliable tool that utilizes the eC-SSRS to assess suicide risk with patients. Used in over 60 global clinical trials to date, AVERT enables clinical trial patients to comfortably and privately respond to a brief, SIB-related interview during investigative site visits. If AVERT identifies an at-risk patient, the investigative site is alerted immediately electronically and via a phone call, enabling them to take appropriate action per the protocol.
Researchers interested in learning more about the study’s findings and about suicide risk assessment in clinical development can view posters and/or participate in the following upcoming industry events:
- Sept. 30 - Oct. 2, 2013: International Society for CNS Clinical Trial Methodology (ISCTM) Autumn Conference; Philadelphia, PA. The following posters will be presented:
- “Comparing Clinician-rated CSSRS with Computer-administered eC-SSRS (Ver 2.0): Replication and Extension of Prior Research Findings”
- “The Full Range of Lifetime Suicidal Behaviors (Not Just Attempts), Their Total Number and Every Type of Suicidal Ideation Predict Risk of Future Suicidal Behavior”
- Oct. 10, 2013: Live Broadcast – “Meeting Safety Requirements through COA Data Capture - Suicidal Behavior Risk: Assessing & Monitoring in Clinical Trials.” Register here.
- Nov. 14-17, 2013: CNS Summit; Boca Raton, FL. The following posters/sessions will be presented:
- Dr. John Greist will present the poster “Suicidal Behavior Reported During Study Participation: Predictive Relationships with Suicidal Ideation/Behavior Reports Provided at Screening/Baseline”
- Dr. Jean Paty will present the poster “New Technologies Further Enhance Data Quality”
- Dr. John Greist will participate in the panel, “Collaborative Panel: Interactive Session Examining Data Quality Findings in CNS Clinical Trials”
For information on these events, as well as to download the JCP paper and other sources of information on effectively assessing for suicide risk, visit http://www.ert.com/clinical/sra/.
About ERT
ERT (www.ert.com) is a leading provider of high-quality patient safety and efficacy endpoint data collection solutions for use in clinical drug development. ERT delivers a combination of technology, services, and consulting that increase the accuracy and reliability of patient data and improve the efficiency of the clinical development process throughout the product lifecycle. ERT delivers the most widely deployed solutions in centralized cardiac safety, respiratory services, suicide risk assessment and Clinical Outcome Assessments (COA) – which includes patient, clinician, and observer reported outcomes. By efficiently integrating these solutions through a system built upon a scientific and regulatory foundation, ERT collects, analyzes, and delivers safety and efficacy data critical to the approval, labeling, and reimbursement of pharmaceutical products. ERT is a global organization with headquarters in Philadelphia, PA and offices throughout the U.S., U.K., Japan, and Germany.
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