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Ensure patient safety with effective suicide risk assessments

Accurately assessing suicidal ideation and behavior (SIB) is vital to ensure patients who participate 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 a higher risk of SIB. These patient populations may include, but are not 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 or Huntington’s disease.

To learn more about monitoring suicide risk in your clinical trial, read our blogs.

The Columbia‑Suicide Severity Rating Scale (C-SSRS) is the gold standard for monitoring SIB in clinical trials. Talk to Clario about its patient-reported and clinician-reported electronic assessment options designed to suit your study needs.

Suicidal Ideation Table
*Available to site reviewer immediately after assessment is complete and in the Clario 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 are 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

Clario C-SSRS enhances data collection by enabling a trained clinician interviewer to complete the semi-structured assessment via a Clario 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 Clario’s tablet solution.

To monitor suicide risk effectively in your next clinical trial, ask for a demo of Clario’s patient and clinician-reported C-SSRS.