Accurate Suicide Risk Detection With eC-SSRS Helps Ensure Safety of Trial Participants and Treatments in Oncology and Beyond
Timezones:
- North America – 11am EDT
- United Kingdom – 4pm BST
- Central Europe – 5pm CEST
Protecting patients, compounds and proving benefits: How accurately accessing suicide risk detection with eC-SSRS/C-SSRS helps ensure clinical trial participants and their treatments remain safe in oncology and beyond.
Join esteemed speakers, Dr. Kelly Posner, Dr. John Greist and Libby Thomas for a deep dive into the nuances of accurately assessing suicide risk, including how the Columbia-Suicide Severity Rating Scale (Clinician reported: C-SSRS, patient self-report: eC-SSRS) is benefiting clinical trials by protecting patients, protecting drug compounds and more.
Patient safety is priority number one in clinical trials, making accurate and early detection of suicide risk essential. Drug development carries the risk of treatment-emergent depression and suicidal ideation for trial participants, and lack of suicide risk detection prior to treatment has led to drugs receiving “black-box warnings” by the US Food and Drug Administration (FDA). Extensive further testing was required to demonstrate the safety of the drugs before the warnings were removed, and many patients were delayed treatment during the testing period. Regularly administering the C-SSRS/eC-SSRS in clinical trials can help patients remain safe, and it can help prevent mislabeling drugs that do not carry these serious risks. When used at regular intervals, the C-SSRS/eC-SSRS can also be viewed in conjunction with treatment status and patient quality of life to assess levels of suicide risk in therapeutic areas traditionally hard to assess, such as oncology.
Join the featured speakers to explore the benefits of eC-SSRS/C-SSRS in protecting patients. Don’t miss this deep dive into suicide risk detection in oncology and beyond.
Libby Thomas briefly describes what the speakers will be discussing during the webinar on September 5th, 2023
Who should attend?
- CEOs
- Clinical Operations, Clinical Development, Clinical Research
- Clinical Scientists
- Regulatory Affairs
- Procurement
- Outsourcing
- Clinical Data Managers
- Clinical Drug Development
- Clinical Program/Project Manager
- Clinical Trial Lead
- Sr. Manager, Trial initiation
- Data Science
- Digital Health
- Digital Operations
Attendees will discover:
- Why C-SSRS is the recognized gold standard for assessing present suicidal ideation and past suicidal behaviors that increase risk of future suicide
- How eC-SSRS provides the clearest signal of risk through:
- administration consistency and
- greater patient candor disclosing stigmatized suicidal information by self-report to a computer compared with face-to-face clinician interview
- How eC-SSRS also:
- eliminates transcription errors
- reduces site-staff burden
- provides immediate reports for further clinical evaluation of suicide risk
- reduces liability risk
- costs less
Speakers
Libby Thomas, M.S.
Scientific Advisor, eCOA Science and Consulting at Clario
Libby Thomas is a Scientific Advisor at Clario, utilizing her curiosity and knowledge of human behavior to provide scientific consultation on electronic clinical outcome assessments (eCOA) in the clinical trial space. Her focus includes diary design best practice, patient advocacy and human-centered design.
Libby began her education studying the implementation of brain-computer interfaces in patients with locked-in syndrome in the lab of the late Dr. Emanuel Donchin. She continued her studies and research working daily with participants with schizophrenia, schizo-affective disorder and bipolar disorder for four and a half years corresponding with her graduate studies at the University of Georgia.
During this time, she set up and analyzed data from electroencephalograms and magnetoencephalograms, allowing her to gain hands-on knowledge and a deeper understanding of where the activities of the human brain overlap with physics (e.g. electrical and magnetic activity). She has authored and co-authored numerous academic works and publications. And, because she likes to know how everything works, she occasionally dabbles in solution and software design.
Kelly Posner, Ph.D.
Professor of Psychiatry, Columbia University
Dr. Kelly Posner Gerstenhaber is a Professor of Psychiatry at Columbia University, and her work is saving lives all over the globe. Her work has been noted in a White House keynote speech and Congressional hearings, including her presentation in a US Senate forum on school safety in partnership with the Parkland community. Through her advocacy she has helped change local, national and international policy, which in turn has contributed to reductions in suicide across all sectors of society.
Dr. Posner’s work with the Columbia Protocol is now policy across all 50 states, national agencies and most countries. The US Food and Drug Administration (FDA) has characterized her work as “setting a standard in the field” and a lead article in The New York Times called it “one of the most profound changes of the past sixteen years to regulations governing drug development.” Her scholarly work has been included in the compendium of the most important research in the history of the study of suicide and was recognized as one of top 20 most cited papers from Columbia faculty over the past 10 years.
Dr. Posner has been awarded the United States Secretary of Defense Medal for Exceptional Public Service.
John Greist, M.D.
Chairman of the Board, Meret Solutions;
Emeritus Professor of Psychiatry, Univ. Of Wisconsin School of Medicine and Public Health
John is MERET Solutions’ Chairman of the Board and Co-Founder, Research Professor (Volunteer) for the Department of Psychiatry and Behavioral Sciences School of Medicine-Wichita at the University of Kansas and also Emeritus Professor of Psychiatry at the University of Wisconsin School of Medicine and Public Health. One of the pioneers in the field of computerized medicine, he co-founded Epic Systems Corporation, PRN Systems, and Healthcare Technology Systems and is board certified in psychiatry and a distinguished life fellow of the American Psychiatric Association.
Dr. Geist has major clinical and research interests in anxiety and mood disorders, suicidality, psychopharmacology, cognitive behavior therapy and clinical applications of computing. He has coauthored over 300 publications including Antidepressant Treatment, Depression and Its Treatment, Anxiety and Its Treatment, Primer of Lithium Therapy, Lithium Encyclopedia for Clinical Practice, Fearless Flying, Run to Reality, and patient booklets in the Madison Institute of Medicine series on Antipsychotic Medications and Schizophrenia; Carbamazepine and Manic Depression; Depression and Antidepressants; Fearful Flyer’s Guide; Lithium and Manic Depression; Obsessive Compulsive Disorder; Panic Disorder and Agoraphobia; PMDD; Alzheimer’s Disease; and Social Phobia.