Suicidality and Risk of Suicide-Definition, Drug Safety Concerns, and a Necessary Target for Drug Development: A Brief Report
Suicidality and Risk of Suicide-Definition, Drug Safety Concerns, and a Necessary Target for Drug Development: A Brief Report
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DOI：
10.4088/jcp.10cs06070blu
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发表时间：
2010-08-01
影响因子：
5.3
通讯作者：
Sheehan, David V.
中科院分区：
文献类型：
--
作者：
Meyer, Roger E.;Salzman, Carl;Sheehan, David V.
目的：为了解决潜在的治疗新出现的“自杀”问题，2009年3月23-24日召开了一次共识会议。参与者：来自学术界、政府和工业界的与会者聚集了自杀预防、临床试验设计、心理计量学、药物流行病学和遗传学方面的专家，以及参与研究与整个生命周期自杀风险增加相关的精神障碍研究的精神病学家。这一过程包括对相关文献的审查，并举行了一系列6次分组会议，集中讨论感兴趣的具体问题。证据：每个与会者在会议前都收到了与正式报告相关的参考资料(以及报告的幻灯片)，供其审查。此外，还回顾了自杀意念/行为的评估工具与有效性、可靠性和临床效用的标准测量之间的关系，这些发现在相关的突破组、最后的全体会议和本文的准备过程中进行了详细的讨论。协商进程：在全体会议期间，每次正式发言后都要进行讨论并提出问题。指导委员会成员和每个分组主席事先为每个分组准备了大约6个问题。突破小组的共识是通过名义小组过程达成的。最后一次全体会议对每个分组的协商一致建议和任何异议进行了审查。所有全体会议都由一名法庭速记员记录和转录。在成绩单之后，在每个作者的输入下，最后的论文经过了14次草稿。会议的成果编入了这份简短的报告和摘录的随附全文。全文由两位作者撰写，并听取了会议所有与会者的反馈，代表了一种共识观点。结论：自杀一词在临床上并不像更具体的术语(意念、行为、企图和自杀)那样有用。大多数与会者对FDA鼓励标准定义和对调查人员和行业赞助商的可定义期望表示赞赏。需要对可用的评估工具进行进一步研究，以验证它们在识别自杀治疗相关的紧急不良反应和/或自杀预防试验中的有效信号方面的实用性、可靠性和有效性。FDA需要通过鼓励开发一种有效的工具来对自杀想法、行为和风险进行上市后监测，从而系统地监测上市后的事件。随着时间的推移，FDA、行业和临床研究人员应该评估所有中枢神经系统临床药物试验必须包括与哥伦比亚自杀评估分类算法(C-CASA)兼容的筛查工具的要求的影响，以评估和记录治疗紧急自杀意念和行为的发生。最后，如果采取适当的预防措施，自杀高危患者可以安全地纳入临床试验。临床精神病学杂志2010；71(8)：1040-1046(C)版权所有：医师研究生出版社，2010年。
Objective: To address issues concerning potential treatment-emergent "suicidality," a consensus conference was convened March 23-24, 2009.Participants: This gathering of participants from academia, government, and industry brought together experts in suicide prevention, clinical trial design, psychometrics, pharmacoepidemiology, and genetics, as well as research psychiatrists involved in studies in studies of psychiatric disorders associated with elevated suicide risk across the life cycle. The process involved reviews of the relevant literature, and a series of 6 breakout sessions focused on specific questions of interest.Evidence: Each of the participants at the meeting received references relevant to the formal presentations (as well as the slides for the presentations) for their review prior to the meeting. In addition, the assessment instruments of suicidal ideation/behavior were reviewed in relationship to standard measures of validity, reliability, and clinical utility, and these findings were discussed at length in relevant breakout groups, in the final plenary session, and in the preparation of the article. Consensus and dissenting views were noted.Consensus Process: Discussion and questions followed each formal presentation during the plenary sessions. Approximately 6 questions per breakout group were prepared in advance by members of the Steering Committee and each breakout group chair. Consensus in the breakout groups was achieved by nominal group process. Consensus recommendations and any dissent were reviewed for each breakout group at the final plenary session. All plenary sessions were recorded and transcribed by a court stenographer. Following the transcript, with input by each of the authors, the final paper went through 14 drafts. The output of the meeting was organized into this brief report and the accompanying full article from which it is distilled. The full article was developed by the authors with feedback from all participants at the meeting and represents a consensus view. Any areas of disagreement at the conference have been noted in the text.Conclusions: The term suicidality is not as clinically useful as more specific terminology (ideation, behavior, attempts, and suicide). Most participants applauded the FDA's encouragement of standard definitions and definable expectations for investigators and industry sponsors. Further research of available assessment instruments is needed to verify their utility, reliability, and validity in identifying suicide-associated treatment-emergent adverse effects and/or a signal of efficacy in suicide prevention trials. The FDA needs to systematically monitor postmarketing events by encouraging the development of a validated instrument for postmarketing surveillance of suicidal ideation, behavior, and risk. Over time, the FDA, industry, and clinical researchers should evaluate the impact of the requirement that all central nervous system clinical drug trials must include a Columbia Classification Algorithm of Suicide Assessment (C-CASA)-compatible screening instrument for assessing and documenting the occurrence of treatment-emergent suicidal ideation and behavior. Finally, patients at high risk for suicide can safely be included in clinical trials, if proper precautions are followed. J Clin Psychiatry 2010;71(8):1040-1046 (C) Copyright 2010 Physicians Postgraduate Press, Inc.