On April 6, 2011, ERT held a webinar on prospectively monitoring for suicidality in non-mental health indications that included guest speakers: Kelly Posner, Ph.D, Columbia University, John Greist, M.D., HTS, and Michael Federico, VP ePRO Solutions, ERT. Such an important issue drew in a crowd of over 300 registrants and the cutting edge subject generated a great deal of questions, as well as requests for additional information. So by popular demand, we scheduled a one hour follow-up session with the speakers three weeks later, on April 27. We asked our speakers to reconvene for two reasons: first, to review the implementation and operations aspects of this unique solution, and second to devote 40 minutes exclusively to Q&A.
During the initial webinar, Dr. Kelly Posner first discussed the need for prospective suicidality monitoring and explained a method of prospective assessment which improves precision and reduces site burden by using the Columbia-Suicide Severity Rating Scale (C-SSRS). Topics included early suicidality monitoring, the FDA Guidance and the rationale behind it, the problem with inaccurate and inconsistent definitions of suicidal acts, how the C-SSRS can accurately and reliably assess suicidality, and indications of its current use in clinical trials. Dr. Greist then came on to introduce the self rated C-SSRS, or the eC-SSRS. Dr. Greist discussed key concepts, the eC-SSRS in practice, appropriate subjects (younger populations, those with Alzheimer’s and cognitively impaired patients), and the many benefits the eC-SSRS has to offer. Finally, Michael Federico presented a brief operational overview of the eC-SSRS which included information relating to study planning, startup and applications.
Throughout the webinar, we held several small polls for our attendees to answer in order to assess how the industry views prospectively monitoring for suicidality using the C-SSRS and eC-SSRS. The questions and responses are as follows:
Do you agree prospectively monitoring for suicidality in your trial using the C-SSRS will reduce the number of positive reports?
73.30% of people strongly agree or agree that prospectively monitoring for suicidality in your trial using the C-SSRS will reduce the number of positive reports
Now consider the IVR or telephone based method of using the SSRS. Is this an appropriate method of electronically administering the SSRS?
75% of people believe that the IVR or telephone based method is a very appropriate or appropriate way of electronically administering the SSRS
Will the eC-SSRS reduce the investigator burden as compared to performing all the C-SSRS via patient interview.
89% of people believe the eC-SSRS will reduce the investigator burden to some degree as compared to performing all the C-SSRS via patient interview.
The Q&A session that followed the initial webinar proved very valuable, providing our audience with an in-depth view of how to implement the eC-SSRS in their clinical trials. Each speaker was given a significant amount of time to personally answer the most important questions and concerns from the audience. These questions and answers have been used to create a formalized FAQ document that can now be found on our website. Please visit http://www.ert.com/ec-ssrs-faq/ for more details.
Also, if you would like to view either webinar please click on the links below or request a copy of the presentation by emailing events@ert.com.
Click to View: Prospectively Monitoring for Suicidality in Non-Mental Health Indications
Click to View: Bonus Q&A Session
