Sponsors, CROs, sites, and anyone else involved in running clinical trials must consider the risk of suicidality. But deep-rooted misconceptions get in the way.
Each year, 703,000 people die by suicide.[1] The rate is rising, especially in the US. In fact, more people died from suicide in the US in 2022 than in any year on record, according to CDC data. The rate of 14.9 deaths for every 100,000 people represents a 10% jump over 2018[2]
Clearly, site staff and Principal Investigators need the ability to assess suicidality risk across all trials. To achieve this, it is essential to dispel three prevalent myths.
Myth 1: Suicidality is a problem only in psychiatry trials.
“We don’t see suicidal patients at our site since we don’t do psychiatry studies,” a Principal Investigator recently said. Contrary to this popular belief, suicidality is not confined to psychiatry or even CNS trials.
Not all individuals with mental illness experience suicidal thoughts, and suicide is not exclusive to those with diagnosed conditions. Surprisingly, approximately 54% of individuals who die by suicide do not have a mental health disorder. [3]
Several conditions are associated with increased suicide and suicidal ideation, including:
- Cancers: The prevalence of suicide is 20% higher than those without cancer.[4]
- Overweight and obesity: Self-identification as ‘overweight’ is associated with significantly higher odds of suicidality, compared to those who don’t identify as overweight.[5]
- Migraine: A 2023 meta-analysis identified a “significant association between migraine and suicide ideation and attempts.”[6]
Myth 2: Existing scales are adequate for assessing suicidality.
The Columbia-Suicide Severity Rating Scale (C-SSRS) assesses the severity and immediacy of suicide risk, but it doesn’t provide the context many sites and study teams require. WCG offers additional training for research sites, giving them the insight and knowledge they need to understand the issues around suicidality. After all, clinical judgments require more than the standardized risk assessment results.[7]
That requires training.
Myth 3: Healthcare professionals are comfortable discussing suicidality and don’t need additional training.
In fact, the opposite is true. Research suggests that medical professionals are more likely to stigmatize suicidal patients compared to the general population. This calls into question the current training around suicidality.[8]
Done well, site training reduces stigma and equips site teams with the skills to handle suicidality cases with sensitivity and professionalism. The proper training also helps ensure site staff are well-prepared for evaluations using standardized tools. And it’s available now.
Tailored, User-Friendly Training
The C-SRSS is available on WCG InvestigatorSpace® in over 30 languages, but that’s just the baseline. WCG goes further by providing additional suicidality training tailored to clinical research sites. These user-friendly, modular trainings, also available on the InvestigatorSpace portal, are designed for easy deployment, management, and tracking. Written to be as non-technical as possible, these modules are accessible to all the sites participating in a trial.
The core module offers general guidelines for clinical research professionals, even those with limited mental health experience, to conduct suicidality assessments. It covers myths and facts about suicide, risk factors, warning signs, and provides specific, non-technical guidance for evaluating suicidal thinking and behavior. This module is generic and can be used across various studies and indications without modification.
Indication-specific modules address considerations related to obesity, migraines, and other conditions, highlighting risk factors and essential comorbidities. Training also includes adolescent and pediatric supplemental training. WCG also offers the flexibility to develop customized supplemental training based on a sponsor’s protocol.
Visit wcgclinical.com/investigatorspace representative to explore our training solutions. Identifying suicidality early enhances participant well-being and supports clinical trial success.
[1] World Health Organization. Suicide. August 28, 2023. https://www.who.int/news-room/fact-sheets/detail/suicide
[2] suicide deaths reached a record high in the US in 2022. CNN. Published August 10, 2023. https://www.cnn.com/2023/08/10/health/suicide-deaths-record-high-2022/index.html
[3] NAMI “5 Common Myths About Suicide Debunkedhttps://www.nami.org/Blogs/NAMI-Blog/September-2020/5-Common-Myths-About-Suicide-Debunked
[4] Fernando A, Tokell M, Ishak Y, etc. Mental health needs in cancer – a call for change. Future Healthc J. 2023;10(2):112-116. doi:https://doi.org/10.7861/fhj.2023-0059
[5] Haynes A, Kersbergen I, Sutin A, Daly M, Robinson E. Does perceived overweight increase risk of depressive symptoms and suicidality beyond objective weight status? A systematic review and meta-analysis. Clinical Psychology Review. 2019;73:101753. doi:https://doi.org/10.1016/j.cpr.2019.101753
[6] Wei H, Li Y, Lei H, Ren J. Associations of migraines with suicide ideation or attempts: A meta-analysis. Front Public Health. 2023;11:1140682. Published 2023 Mar 24. doi:10.3389/fpubh.2023.1140682
[7] Harmer B, Lee S, Duong TvH, et al. Suicidal Ideation. StatPearls Publishing; 2023 Jan. https://www.ncbi.nlm.nih.gov/books/NBK565877/
[8] Eilers JJ, Kasten E, Schnell T. Comparison of Stigmatization of Suicidal People by Medical Professionals with Stigmatization by the General Population. Healthcare (Basel). 2021;9(7):896. Published 2021 Jul 15. doi:10.3390/healthcare9070896
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