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Applied Clinical Trials
This article will analyze factors that affect suicidal ideation from a clinical psychiatric pilot study.
The need for robust and standardized psychiatric outcomes measures in clinical trials has increased in importance over the past several years. Biopharmaceutical enterprises are paying close attention to payer scrutiny in evaluating the value of new medical products, particularly in oncology and orphan disease indications. Governmental reimbursement authorities and payers are now requiring data that not only demonstrate the scientific value of a medical product, but also show improvements in a patient’s quality of life (QOL)1 during reimbursement review.
Biopharmaceutical companies are touching on the notion of introducing clinical interventions during clinical trials, such as palliative care methodology,6 in order to better demonstrate the impact of their medical products in improving patient QOL outcomes. However, significant psychological effects, such as suicide ideation, are becoming critical points of measurement in QOL outcomes, and biopharmaceutical enterprises are limited to very few validated psychological assessment systems. This article will analyze factors that affect suicidal ideation from a clinical psychiatric pilot study.
Suicide Risk in Cancer Patients
Many patients experience psychological problems when they have been diagnosed with cancer, and undergo oncology treatment. Patients experience significant psychological effects from facing death, financial issues, emotional ties with friends and family, and adverse medical outcomes from oncological therapy. The psychological effects are so severe that some patients consider suicide. In fact, cancer patients are twice as likely to commit suicide compared to the general population,2 and biopharmaceutical sponsors are increasingly utilizing suicidal risk assessment tools in their protocols after the release of FDA’s suicidal ideation and behavior guidance document,3 which encourages sponsors to prospectively assess suicidal ideation in clinical trials,4 and recommends that sponsors use the Columbia Suicide Severity Rating Scale (C-SSRS) in clinical trial design.5
While these scales obviously ask patients about killing themselves, patients may not be truthful about their feelings of suicidal ideation due to fear that they may no longer qualify for an oncology clinical trial, according to qualitative patient feedback. With emerging data from psychiatric treatment databases, researchers are now closer towards identifying suicidal patients through a variety of factors, such as religious beliefs, drug and alcohol abuse, marital status, sleeping patterns, and much more.
The Treatment Online Pilot
Treatment Online is a validated online psychiatric platform that engages patients and clinicians. The platform is capable of collecting patient reported outcomes through validated and licensed measures including Beck Scales, mood measurement, drug side effect reporting, and socioeconomic behaviors for a variety of psychiatric indications. Over the course of five years, Treatment Online ran a pilot on and collected data from nearly 2,000 patients in New York City.
Factors that Impact Suicide and Depression
In this case study, we evaluated factors impacting depression, suicidal thoughts and suicidal plans.
Figure 1 analyzes the impact of marital status on patients who have suicidal thoughts. The visualization suggests that patients who are single are associated with exhibiting higher levels of having suicidal thoughts compared to those who are married. The variance assessment (grey line) demonstrates the differences in those populations, and an increasing trend confirms the aforementioned risk.
Figure 2 illustrates the impact of religious beliefs on depression. This analysis suggests that patients with Agnostic and Atheist beliefs tend to exhibit higher levels of depression compared to Judaism, Catholicism Islam, and some religions. Nonetheless, Protestants and other religions exhibited similar patterns of higher depression rates compared to non-depression rates. The variances (grey line) further reveal the differences in depression rates within specific religions, with Judaism showing the highest variance in depressed/non-depressed patients.
Figure 3 demonstrates the impact of a breakup of a relationship with suicidal plans. Patients who have experienced a breakup in a relationship is associated with higher rates of developing plans of suicide compared to those who did not experience a breakup. This factor poses a critical risk in suicidal evaluation, as cancer patients as well as their families face the notion that their loved ones may depart.
Figure 4 evaluates the impact of suicidal thoughts on sleeping difficulty. This analysis clearly delineates that patients who have suicidal thoughts are much more likely to experience sleeping difficulties compared to those who do not have suicidal thoughts.
Benefits to Clinical Trials and Palliative Care
Biopharmaceutical sponsors can leverage validated and licensed psychiatric scales in order to assess the impact and progression of suicidal ideation in cancer clinical trials. Moreover, study teams can leverage the aforementioned data analyses to not only develop predictive and risk models on suicidal ideation, but also create analytical benchmarks to improve sensitivity analyses.
This data can also benefit palliative care in healthcare settings and clinical trials, as understanding factors that affect suicidal ideation can impact intervention in palliative care. For example, Figure 2 suggests that surrounding patients with a sense of religion and hope can assist with reducing depression, and weaving family/close relationships with patients can help cancer patients with improving suicidal ideation outcomes.
Albeit regulatory agencies traditionally focused on the scientific value of a medical product, they are now starting to look at patient QOL perspectives in the approval process.8 Pairing the medical products with clinical intervention and palliative care during clinical trials can enhance therapeutic benefits, and improve the success of not only regulatory acceptance, but also payer reimbursement approval, and patient support.