Monitor suicide ideation and behavior (SIB) effectively
ERT’s suicide assessment tool, eC-SSRS, can electronically report patient and clinician responses in real-time.
ENSURE PATIENT SAFETY WITH
EFFECTIVE SUICIDE RISK ASSESSMENTS
Accurately assessing suicidal ideation and behavior (SIB) is vital to ensure patients who take part in clinical trials remain safe from treatment-related suicide risk. According to the FDA a SIB assessment, such as the Columbia-Suicide Severity Rating Scale (C-SSRS) should be included in clinical trials involving:
- Isotretinoins / tretinoins
- Beta-blockers that cross the blood-brain barrier
- Reserpine (for smoking cessation)
- Weight loss drugs
- Anti-epileptic drugs or other neurologic drugs with central nervous system activity
- Any pharmacologically-similar drug
- Any psychiatric indication e.g., bipolar disorder, schizophrenia, major depressive disorder, ADHD, OCD, panic attacks, PTSD, generalized anxiety disorder and autism spectrum disorder
- Multiple-dose phase 1 trials with healthy volunteers
We further recommend assessing suicide risk in clinical trials involving patient populations with higher risk of SIB. These patient populations may include, but not be limited to:
Asthma, back pain, brain injury, cancer, congestive heart failure, chronic obstructive pulmonary disorder, diabetes, epilepsy, HIV/AIDS, heart disease, hypertension, migraine, Parkinson’s disease, renal disorder, sleep disorders, stroke, multiple sclerosis, lupus, Huntington’s disease.
To learn more about monitoring suicide risk in your clinical trial, read our blogs.
RAPIDLY DETECT TREATMENT-RELATED SUICIDE RISK
The Columbia‑Suicide Severity Rating Scale (C-SSRS) is the gold standard for monitoring SIB in clinical trials. Talk to ERT about its patient-reported and clinician-reported electronic assessment options to suit your study needs.
*Available to site reviewer immediately after assessment is complete and in the ERT Portal as soon as the data transfer occurs
Patient-reported eC-SSRS ePRO assessments
Enabling patients to self-report on SIB, either via a tablet, browser or IVR, leads to more honest answers and higher quality data (inter-rater variability and bias is eliminated). Critically, the identification of positive signals happens much faster, generating real-time alerts to clinicians for speedier follow-up. Self-reporting also saves clinicians time, eliminating the need for them to carry out assessments themselves and avoiding the need for training.
Clinician-led C-SSRS eClinRO assessments
ERT C-SSRS enhances data collection by enabling a trained clinician interviewer to complete the semi-structured assessment via an ERT eCOA Tablet device during a patient site visit. This reduces site burden, administration errors, missing data, and transcription errors. Access to near real-time reporting is available through ERT’s tablet solution.
Global biotech rapidly detects SIB with patient-reported data
Read how one biotech’s use of ERT’s exclusive patient-reported eC-SSRS provided them and the FDA with evidence of a SIB risk associated with the treatment. The trial was then terminated early — potentially saving further lives.