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News

eResearchTechnology introduces new suicidality screening solution

EResearchTechnology : 23 June, 2008  (New Product)
eResearchTechnology has introduced the EXPeRT ePRO Suicidality Monitoring System (SMS) which provides suicidality screening required in a growing number of drug development programmes as a part of effective drug profiling and subject safety monitoring in clinical trials.
The SMS was developed to address regulatory concerns and reduce the cost and time associated with clinician-administered suicidality assessments.

The system will also improve the quality of suicidality assessments compared to those performed by clinicians alone. SMS was developed in conjunction with Drs John Greist, Alan Gelenberg, James Mundt, David Katzelnick and Jeff Jefferson. The system is the most recent addition to a growing line of telephone-based assessments within the EXPeRT ePRO services offered by eRT.

SMS is a simple patient monitoring and alert tool. It enhances subject comfort while generating critical information for site research staff and investigators in evaluating suicidality risk factors. It is easily added to any clinical trial. If a potential suicidality signal is detected for a subject, the SMS promptly alerts the investigator site to permit more in-depth clinical follow-up and evaluation.

Dr John Greist, an eRT consultant with decades of experience and research on computer interviewing, described some of the benefits of SMS: 'SMS provides a user-friendly telephone interface as a computer terminal to collect sensitive suicidality data directly from trial subjects. Advantages of Interactive Voice Response (IVR) technology are: constant availability; reliable, consistent, and complete presentation of every question; electronic recording of respondents' answers; documentation of the assessment completion; and prompt feedback and reporting to the study sites.


Patients are more likely to disclose sensitive subject matter, including suicidality, in computer interviews than they will to human interviewers. The SMS models the ideal human interviewer, comprehensively and consistently covering every relevant topic while efficiently branching around irrelevant questions. Sound science requires standardisation of measurement; the SMS provides a standard of procedural reliability that surpasses the reliability of human investigators performing such assessments.'

'Just as the use of digital ECGs in assessing cardiac safety has become an essential part of drug development, we believe that the use of SMS in assessing suicidality will also become an integral part of the drug development process,' said Jeffrey S Litwin, MD, eRT's chief medical officer.

EXPeRT ePRO was launched by eRT in conjunction with Healthcare Technology Systems (HTS), a leading authority in the research, development and validation of computer administered clinical rating instruments. The service uses HTS' expertise and eRT's existing infrastructure and role as a leading provider of clinical solutions to the pharmaceutical, biotechnology, medical device and related industries.

Electronic patient reported outcome (ePRO) assessments are standardised, with all questions asked and scored by direct automated methods from trial subjects at any location with telephone access. Additionally, ePRO assessments provide subject response checking during interviews, offer immediate data storage to prevent potential data loss, and improve the accuracy and timeliness of subject data entry and increased clinical study efficiencies.

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