Monitor suicide ideation and behavior (SIB) effectively
ERT’s suicide assessment tool can electronically report patient and clinician feedback 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 when the following indications are involved:
- 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
To learn more about when and why to include suicide risk monitoring in your clinical trial, read our blog.
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, reduces transcription errors and enables access to near real-time reporting.
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.
To monitor suicide risk effectively in your next clinical trial, ask for a demo of ERT’s patient and clinician-reported C-SSRS.