eResearch Technology, the US-based supplier of centralised electrocardiographic, eClinical technology and electronic patient-reported outcomes services, has launched a suicidiality monitoring system to “address regulatory concerns and reduce the cost and time associated with clinician-administered suicidiality assessments”.

The EXPeRT ePRO Suicidiality Monitoring System is the latest addition to a growing line of telephone-based assessments within the EXPeRT ePRO services offered by eRT, the company noted. The system employs Interactive Voice Response Technology to set up a user-friendly telephone interface as a computer terminal that can collect sensitive suicidiality data directly from clinical trial participants.

“Patients are more likely to disclose sensitive subject matter, including suicidiality, in computer interviews than they will to human interviewers,” noted Dr John Greist, an eRT consultant who was involved in developing the new tool. If a potential suicidiality signal is detected, the SMS promptly alerts the investigator site to enable more in-depth clinical follow-up and evaluation.

As eRT pointed out, suicidiality screening is required in a growing number of drug development programmes as a component of effective drug profiling and safety monitoring of trial subjects. Earlier this year the US Food and Drug Administration dismissed a report in The New York Times that the agency had radically changed its policy on tracking potential risks of suicidiality in clinical trials.

“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 suicidiality will also become an integral part the drug development process,” commented Dr Jeffrey Litwin, eRT’s chief medical officer.