Pharmaceutical-Funded Research - The Columbia Lighthouse Project

Asking About Suicide Is Vital in Pharmaceutical Research

According to the U.S. Food and Drug Administration (FDA), there are two reasons for prospectively assessing suicidal ideation and behavior in clinical trials:

To ensure that patients in clinical trials who are experiencing suicidal ideation and behavior are properly recognized and adequately treated
To make it easier to detect increases in suicidal ideation and behavior in individual trials and in pooled analyses

The assessments also are critical in clinical trials for a third reason: to avoid misclassification of ideation and behaviors as suicidal, which can overestimate the true risk and result in the overly conservative use of the drug or its lack of availability entirely. Conversely, missing a signal of increased risk would result in greater comfort than is warranted in the safety of a drug. In either case, the use of the C-SSRS promotes decisions based on scientific evidence and a better-informed risk-benefit analysis.

According to the FDA, prospective suicidal ideation and behavior assessments should be carried out in almost all clinical trials that involve the development of a drug for any type of psychiatric indication, as well as for any anti-epileptic drugs or other neurologic drugs with central nervous system activity.

The C-SSRS Is the Gold Standard

The Columbia-Suicide Severity Rating Scale (C-SSRS) is the only risk assessment tool specifically identified by the FDA as acceptable for use in clinical trials. Often referred to as the gold standard, the C-SSRS is used in clinical trials throughout the U.S. and around the world. The C-SSRS is the ideal risk assessment tool for clinical research because it’s:

Simple. Ask all the questions in a few moments or minutes — with no mental health training required to ask them.
Evidence-supported. An unprecedented amount of research has validated the relevance and effectiveness of the questions used in the C-SSRS to assess suicide risk, making it the most evidence-based tool of its kind.
Universal. The C-SSRS is suitable for all ages and special populations in different settings and is available in more than 100 country-specific languages. This includes modifications that provide ways of asking the questions of younger children and people with autism, dementia, or other developmental or intellectual disabilities.
Effective. Real-world experience and data show that the scale has helped prevent suicide.
Efficient. Use of the scale redirects resources to where they’re needed most. It reduces unnecessary referrals and interventions by more accurately identifying who needs help — and makes it easier to correctly determine the level of support a person needs, such as patient safety monitoring procedures, counseling, or emergency room care.

Licensing

A licensing agreement is required to use the C-SSRS in clinical trials. Licenses are issued on a per-protocol basis and cover all available time-frames and translations of the scale. The Research Foundation for Mental Hygiene Inc., the parent organization of The Columbia Lighthouse Project, holds the C-SSRS copyright. The foundation is a not-for-profit corporation organized in 1952 to assist and enhance the research and training objectives of the New York State Department of Mental Hygiene, including its Office of Mental Health.

For permission to use the hard-copy C-SSRS in a clinical trial, please submit a request. Include the protocol number, study phase number, treatment indication, and total number of C-SSRS administrations per protocol (the estimated number of enrolled subjects multiplied by the number of C-SSRS assessment points in the protocol). Once your request is processed, you will receive an email granting immediate permission to use the C-SSRS in your study, along with instructions for initiating a licensing agreement.

Licensing for the Electronic C-SSRS

The eC-SSRS — a computer-automated, patient-reported C-SSRS — provides numerous benefits for clinical researchers. Requests to use the eC-SSRS should be submitted to CLARIO (see the request form at bottom of the CLARIO page).

Rater Training and Certification for Clinical Trials

Anyone can administer the C-SSRS for clinical trials, regardless of education level, as long as the administrator views the C-SSRS training video and gets a training certificate. See our information on training for the research setting.

Translations

The C-SSRS is available in more than 130 country-specific languages. The translations for research have undergone rigorous linguistic validation for cross-cultural implementation by MAPI, the leading Patient-Centered Research company serving life science researchers for over 40 years.

Schedule of Assessments

The exact administration schedule depends on study-specific time frames. The following is a typical administration schedule:

Use Baseline-Screening to assess inclusion/exclusion criteria and to provide a pre-treatment assessment at baseline.
On all subsequent visits, use Since Last Visit.

Studies may amend the timeframes (e.g., changing years to months) to suit their research needs. Studies needing to collect data on the 11 suicidal ideation and behavior categories recommended by the FDA in the 2012 “Guidance for Industry Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials”, as well as to shorten administration time, may omit the ideation intensity and behavior lethality sub-scales (sections 2 and 4 on the standard C-SSRS).

Scoring and Data Analysis

Industry professionals collaborated with the Project to develop the C-SSRS Scoring and Data Analysis Guide. The recommendations in the guide are consistent with the most recent FDA industry guidelines for prospectively assessing suicidal ideation and behavior in clinical trials.