Treatment Emergent Suicidal Ideation and Behavior

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