Suicide Risk Assessment (SRA)

Prospective suicide risk assessment is used to measure lifetime suicidal ideation and behavior to provide a baseline and insight into the prospective risk for future suicidal behavior, as well as a means for ongoing monitoring. Here you will find a complete guide to suicide risk assessment in trials and other clinical settings.

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ABOUT THE FDA GUIDANCE ON SUICIDE RISK

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Why collect suicide risk assessment data prospectively? Suicide - A growing concern in clinical development.

When developing new drugs in particular indications and therapeutic areas, there is a risk of treatment-emergent Suicidal Ideation and Behavior (SIB) in clinical trial patients. To address this risk, in August 2012, the FDA issued a revised Draft Guidance on the Prospective Assessment of SIB in Clinical Trials. The guidance highlights the responsibility of study sponsors to ensure the safety of patients in psychiatric and non-psychiatric drug trials falling under the authority of the FDA. 

Further information regarding the FDA guidance is available here: 

PROTECTING PATIENTS. PROTECTING DRUGS.

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The risk of suicidal ideation and behavior is very real and, unfortunately, increasingly common. According to the CDC, suicide was the tenth leading cause of death in the United States in 2010 (the latest year recorded). This increased prevalence of SIB also increases the risk that a patient will exhibit increased suicidal ideation and behavior and – in the very worst cases – commit suicide while taking part in a clinical trial.

Clearly the primary responsibility of sponsors lies in protecting those patients taking part in clinical trials. The importance of patient safety is critical and the implementation of the FDA recommendations helps sponsors prospectively monitor and protect those who are, or could be, at risk.

It is also important that sponsors take the opportunity to ensure that investigational drugs are routinely monitored and fairly protected.

In the rare case that an increase in SIB is detected during a clinical program, the implementations of FDA recommendations allow sponsors to analyze those SIB data that were prospectively collected. This affords the sponsor the opportunity to identify whether the investigational product played any part in this increased SIB.

The implementation of this monitoring also helps enable sponsors to identify and prove that their product does not induce increased SIB. In some indications this can enhance product labeling and positively differentiate drugs versus competitive molecules.

HOW TO COMPLY WITH THE FDA GUIDANCE?

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The FDA guidance recommends that SIB monitoring is performed at every study visit, including unscheduled visits, during all trials involving compounds falling under the remit of this guidance.

Monitoring is to include a baseline (or lifetime) assessment of all patients when they are first entered into a study. This monitoring then continues at subsequent visits where patients are asked whether there have been any changes in SIB since their last assessment. This allows sponsors to monitor any changes in SIB from initial assessment and between visits.

Any scale used to monitor SIB should directly map to and populate the 11 SIB (formerly C-CASA) categories.

COLUMBIA SUICIDE SEVERITY RATING SCALE (C-SSRS)

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Deployed widely in both clinical practice and clinical research, the C-SSRS is a powerful screening tool that assesses the full range of evidence-based suicidal ideation and behavior items, and provides criteria for next steps. This valuable tool is recommended by numerous international agencies and is available in 100+ languages.

The C-SSRS is currently the only approved scale that meets the FDA Draft Guidance for Prospective Assessment of Suicidal Ideation and Behavior. It is a semi-structured assessment intended for administration by clinicians or study staff during scheduled study visits. It explores suicidal ideation and intensity, as well as behaviors and lethality.

The FDA guidance specifically cites the (C-SSRS) as an acceptable instrument for prospectively assessing SIB in clinical trials. The C-SSRS directly maps to and populates the 11 SIB (formerly C-CASA) categories.

C-SSRS Deployment Options
 
There are multiple options available for the deployment of the C-SSRS in clinical trials. These include:
  1. Traditional paper-based, interview-style assessment performed by site personnel or designated mental health professional.
  2. Digital C-SSRS. Also conducted by site personnel or designated mental health professionals, this electronic version removes the manual processes and double-data entry associated with the paper C-SSRS. This is implemented on tablet technology using ERT’s AVERT platform.
  3. eC-SSRS. An electronic, fully structured, patient self-reported version of the C-SSRS. Available in tablet, IVR and web versions and deployed via ERT’s AVERT platform.

AVERT™

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Intelligent Suicide Risk Assessment in Clinical Research

AVERT is ERT’s electronic suicide risk assessment system that provides simple audio (phone) or visual (web or tablet) solutions that are efficiently and effectively implemented in any clinical study.

When utilizing AVERT, patients or clinicians complete the suicide risk assessment directly in an electronic format. By doing so, investigative sites can count on systematic, comprehensive, and consistent assessments that reduce both patient and site staff burden when compared to traditional paper methods.

AVERT electronically deploys scientifically proven suicide risk assessments, which includes the application the Columbia-Suicide Severity Rating Scale (C-SSRS) and the patient self-reported version of the Columbia (eC-SSRS), which are cited in the draft FDA SIB guidance as acceptable methods for assessing suicide risk. 

The Patient-Reported eC-SSRS 
By working closely with Dr. Kelly Posner, the lead author of the C-SSRS, ERT developed an electronic fully-structured, patient-reported version of the C-SSRS called the eC-SSRS.
The eC-SSRS is available in tablet, IVR and web versions and provides considerable benefits over the traditional C-SSRS. Although very simple and low burden to the patient, the eC-SSRS implements a complex systematic structure of questions that logically branch to appropriate follow-up questions based on patient responses. This self-reported approach increases patient candor and ensures consist deployment across all patients, at all sites, in all languages.

By implementing the eC-SSRS in AVERT, sponsors benefit from:
  • Increased patient candor, resulting in greater clarity of patient risk
  • Elimination of clinician variability across sites, studies and languages
  • Reduced time and effort for site staff, allowing them to better focus their resources 
  • Increased efficiency as a result of complete and immediate data capture, reporting, and alerting
  • Automatic assessment scoring eliminates potential clinician errors
  • Elimination of legibility issues and transcription errors
  • Elimination of costs for paper printing and shipping
  • Programmed error checking eliminates missing data problems, and ensures in-range responses
  • Web reports offers sponsors real-time insight into trial progress
  • Immediate alerts for at-risk patients facilitates proper and swift follow up
eC-SSRS Metrics (as of August 2014)

The Clinician-Rated Digital C-SSRS
ERT has faithfully migrated the paper version of this instrument into an electronic format deployed on the AVERT platform. This digital implementation of the C-SSRS guides clinicians through the C-SSRS in an interview format and allows them to record the responses in an electronic format. 
When capturing these data electronically, sponsors benefit from eliminating issues inherent in the collection of traditional paper-based assessments. These benefits include:
  • Automatic assessment calculations eliminate clinician scoring errors
  • Elimination of legibility issues and transcription errors
  • Elimination of costs for paper printing, shipping and double data entry 
  • Programmed error checking eliminates missing data and ensures in-range responses
  • Automatic assessment scoring eliminates potential clinician errors
  • Elimination of legibility issues and transcription errors
  • Elimination of costs for paper printing and shipping
  • Programmed error checking eliminates missing data problems, and ensures in-range responses
  • On-screen help text assists personnel
  • Web reports offer sponsors real-time insight into trial progress
  • Immediate alerts for at-risk patients facilitates proper and immediate follow up
Click here to learn more about AVERT or to schedule a demo. 

IMPLEMENTATION / OPERATION OF AVERT

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A Guide to Policy and Protocols, Data collection and Data Management

Using AVERT in your trial is like any other clinical test in your protocol.  Very little training for the site and almost no training for the patient is required.  


Overview:
  1. The site registers the patient ID in the system 
  2. The patient contacts the system, enters their patient ID and creates a personal PIN
  3. The patient responds to each question and the system branches and probes as  appropriate, conducting a “perfect” interview, and capturing all of the responses
  4. ERT immediately delivers a findings report for site review 
  5. The site follows up with the patient per the protocol 
  6. ERT calls the site directly if there is a positive finding for suicidal ideation or behavior 
  7. Implementation / Operations Overview Presentation
  8. The eC-SSRS Findings Report
Policy and Protocols
Adding the Columbia scale to your clinical development programs is straightforward.  ERT's scientific consultants as well as Drs. Greist, Jefferson, and Posner are available to work with your medical staff and clinical teams to help create a standard policy for Prospective Assessment of Suicidal Ideation and Behaviors for your compound, therapeutic area, or company. This policy can outline the where – in which compounds, when – to be scheduled in the trial, and how – to implement this assessment.  

The C-SSRS can be added to your protocols as part of your schedule of assessments.  It is generally performed at every visit per standard FDA Guidance.  In addition, an appendix outlining how to perform the eC-SSRS is added to your protocol.   A sample is included here.

Versions - There are two versions of the eC-SSRS
Lifetime –This is the version used for all patients for their first interview.  The time frame is in their lifetime and all questions are poised as “have you ever”.   The Recency portion of the scale confirms if these thoughts or behaviors occurred in the past x months.  This section is programmable for ideation and behavior time periods separately or can be shut off completely.  This is generally used to assess protocol screening / exclusion criteria. 

Since Last Interview – This version is used for all subsequent calls. The system recalls the date of the last interview – even if it was a clinician interview – and poses the questions as “since your last interview, month xx, XX days ago, have you”.  This enables us to collect a continuum of experience for each patient.  

Using the C-SSRS and eC-SSRS – Following the publication of the validation study noted above, the FDA has said that it will accept “mixing” the C-SSRS and eC-SSRS applications in the same trial, if it would facilitate patient monitoring. The data management aspects of this approach are reviewed below.   Some examples of this might be:
  • Implementing the eC-SSRS mid trial 
  • Using the clinician interview (C-SSRS) to follow up on a positive eC-SSRS 
  • Reporting non-interview information, i.e. from a spouse or in case of hospitalization or death 
  • Using the C-SSRS in some countries and eC-SSRS in others
C-SSRS and eC-SSRS Versions - As outlined on the Columbia website, there are numerous C-SSRS versions tailored to fit unique circumstances.  The table below outlines the eC-SSRS application for each C-SSRS version. [eC-SSRS and C-SSRS website]



Project Management
ERT’s standard Project Assurance process, used in over 1,100 active studies around the world, will be used to manage the EXPERT application of the eC-SSRS for your trial.  A project manager will be involved from project kickoff through data close out.  This process is outlined in this presentation; The Study Requirement Specification (PRS) will outline the study specifications including reporting and alerting.  Much more detail is available through your ERT contact and our Project Assurance team.

Training
Everyone using the Columbia scale must be licensed and have been oriented to its content and use.  This training is provided via DVD and live Q/A during the investigator meeting and scheduled by the Center for Suicide Risk Assessment – Dr. Kelly Posner. When the eC-SSRS is used, the license and training are included in the program fees.  

In addition, training for ERT’s EXPERT ePRO system – registering the patient, receiving reports and using the study portal is provided by ERT’s Academy staff at the investigator meeting. Both the Columbia and ePRO training can be completed in an hour.

Data Management

Assessment of Suicidal Ideation and Behavior - Although not yet outlined by the FDA, nor in the Guidance, the industry anticipates the result of this data collection will be the summary tables and listings needed to write this component of the summary of safety for the compound. The attached is the recommended Data Analysis Guide for the C-SSRS developed by an industry workgroup and reviewed by the FDA.  

C-CASA / C-SSRS / eC-SSRS Data - As noted, the C-CASA is in retrospective reviews and results in the most basic findings classifications. The C-SSRS prospectively collects these assessments, enabling the next, more detailed level of findings. Similarly, using the eC-SSRS we capture even more data including all the responses to the probing questions.  Therefore the eC-SSRS database is the most comprehensive, and inclusive of the data items from the C-SSRS and C-CASA.  In this way, the database ERT delivers from the eC-SSRS self-rated interviews can easily be coordinated with any other C-SSRS data collected, or even legacy C-CASA analyses.  

As part of this assessment and data collection effort we will need the ability to gather assessment data from a variety of sources including previous trials and even the current trial due to:
  • Implementing the eC-SSRS mid trial  
  • Using the clinician interview (C-SSRS) to follow up an eC-SSRS  
  • Reporting non-interview information, i.e. from a spouse or in case of hospitalization or death 
  • Using the C-SSRS in some countries and eC-SSRS in others 
While almost all data will be collected through the eC-SSRS system, you still need to have your legacy C-SSRS data collection available for these ad-hoc items.  

Data Specification - ERT’s standard eC-SSRS data specifications. Our project management team will work with you and our data team to modify this specifications document to meet your needs, including coordination with your legacy C-SSRS data collection.

For additional information see our brief FAQ page.