PHILADELPHIA, March 15 /PRNewswire-FirstCall/ -- ERT (Nasdaq: ERES), a leading provider of centralized services to global pharmaceutical, biotechnology and medical device companies, announces a pioneering electronic self-rated version of the Columbia Suicide Severity Rating Scale (C-SSRS) to facilitate compliance with regulatory requirements for prospective monitoring of suicidal ideation and behaviors. The validated eC-SSRS solution, developed in collaboration with the scale lead author, is a cost-effective method of prospectively monitoring for suicidality. It has been designed, in line with anticipated FDA requirements, to reliably and reproducibly assess suicidality in clinical trials; thereby, protecting patient safety while significantly reducing the burden on study sites.
In recent years, there has been increased focus on treatment-emergent suicidality and the development of a reliable assessment method for use in clinical trials to enhance effective patient-safety monitoring. The FDA is developing guidance on regulatory requirements for suicidality monitoring. In light of concerns regarding the burdens placed on investigators, ERT, in collaboration with the scale authors, the Center for Suicide Risk Assessment (CSRA) and Healthcare Technology Systems, developed the eC-SSRS.
Kelly Posner, Director of the CSRA at Columbia University and primary author of the C-SSRS, comments: "The FDA Division of Psychiatry Products has indicated that C-SSRS is an acceptable prospective suicidality monitoring assessment. As primary author of the Columbia-Suicidality Severity Rating Scale (C-SSRS), I believe the eC-SSRS is a faithful and accurate representation of the interview version of C-SSRS and has been carefully designed to produce consistent outcomes."
The eC-SSRS is an electronic self-rated version of the C-SSRS using interactive voice-response technology that has been validated against the C-SSRS. The eC-SSRS is a fully-structured C-SSRS interview comprised of standardized questions, appropriate follow-up questions, error-handling routines and scoring conventions. Similar to the C-SSRS, the eC-SSRS assesses lifetime suicidality during an initial baseline evaluation and then monitors ideations and behaviors at subsequent study visits. This solution allows for timely identification of potential risks and provides prompt feedback to study sites for follow-up and evaluation.
Dr. John Greist, CEO of Healthcare Technology Systems and an eC-SSRS author, commented that the FDA Division of Psychiatric Products (FDA/DPP) has confirmed that they would like to see prospective suicidality monitoring during each visit in every trial, in all development phases after Phase I. The C-SSRS has been identified by the FDA as the only acceptable assessment instrument currently available for monitoring suicidal ideations and behaviors in clinical trials. Dr. Greist said, "The FDA/DPP has indicated that questions regarding the acceptability of the eC-SSRS can be directed to them by letter as part of a formal inquiry to the Division."
The eC-SSRS has been successfully used in a validation study sponsored by a major pharmaceutical company, using psychiatric inpatients and healthy control volunteers. The results demonstrated convergent validity of the eC-SSRS with the Beck Suicide Scale. In addition, inter-rater reliability between the eC-SSRS and human C-SSRS raters was comparable to reliabilities found between the human raters. The study also demonstrated good criterion validity of the eC-SSRS for discriminating known-groups differences between the study samples. Overall, the eC-SSRS displayed its feasibility, reliability and validity for assessing suicidality prospectively.
Michael Federico, Vice President, ePRO Solutions at ERT, explains: "In the history of drug development, every time a new regulation is introduced, the burden falls to the investigator sites. This validated eC-SSRS solution reduces this additional site burden. eC-SSRS is now supporting several ongoing clinical trials in large and mid-sized pharmaceutical companies."
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Based in Philadelphia, PA, ERT (eResearchTechnology, Inc.) (www.ert.com) is a global provider of technology and services to the biopharmaceutical, medical device, and related industries. The Company is the market leader in providing centralized core-diagnostic electrocardiographic (ECG) technology and services to evaluate cardiac safety in clinical development. The Company also provides technology and services to streamline the clinical trials process by enabling its customers to automate the collection, analysis, and distribution of clinical data in all phases of clinical development.
Statements included in this release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve a number of risks and uncertainties, which could cause actual results to differ materially from those expressed or implied from such statements. These risks and uncertainties include, without limitation, the Company's ability to obtain new contracts, variability in size, scope, and duration of projects, integration of acquisitions, competitive factors, technological development, market demand, and other factors described in the Company's filings with the Securities and Exchange Commission. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
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