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The concept of treatment emergent suicidality during clinical trials has been a subject of regulatory and research interest, especially since the early 1990s. A key series of analyses have shaped the regulatory environment for expectations of prospective assessment of suicidal ideation and behavior (SIB) in clinical trials. The development of a scale for prospective assessment of these events has been a key priority in order to detect emergent signs during the course of a clinical trial and to assist in patient selection criteria of suicide risk. The maturing regulatory environment and increasing evolution in thinking on definitions of SIB have underpinned significant changes in the main assessment scale, the Columbia Suicide Severity Rating Scale (C-SSRS), as well as in the standard adopted by the FDA for coding, summarizing, and analyzing SIB data, the Columbia Classification Algorithm for Suicide Assessment (C-CASA). For new drugs undergoing clinical development, assessment of SIB is incorporated into benefit/risk decision-making and continuing risk management approaches throughout the pharmaceutical industry and academia. A number of companies have developed internal guidances, which may include quantitative decision-criteria (i.e., based on binding data at CNS targets) or qualitative clinical judgment (i.e., based on mechanistic understanding and emerging safety profiles) of drug candidates that may require the inclusion of prospective SIB tools. In this chapter, we will provide an overview of the regulatory history surrounding treatment emergent SIB and will outline a number of structured qualitative steps for prospective SIB assessment.

DOI: 10.1007/978-3-319-09964-4_3

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