In Reply We are gratified to know that the FDA is developing guidance that supports inclusion of individuals with suicidal ideation or behavior associated with serious mental illnesses, including schizophrenia and bipolar disorder, in clinical trials. We agree that trial participants with acute suicidal ideation or behavior, including those in the control groups of clinical trials evaluating suicidal ideation or behavior as an end point, be provided with standard-of-care (including emergency) interventions or with investigational approaches hypothesized to be as good as or better than the standard of care. However, mandating participant exclusion when suicidal ideation or behavior passes a predetermined threshold is a step backward: drawing conclusions about new treatments for the population most at risk would be impossible.
Sisti DA, Joffe S. Challenges in Research on Suicide Prevention—Reply. JAMA. 2019;321(11):1105–1106. doi:10.1001/jama.2018.21963
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