DDT-COA-000-163 Accelerating the FDA COA Qualification Plan for the PSYCHS as a ClinRO measure

摘要 临床精神病高危综合征(CHR-P)是一种常见的精神疾病，在 美国精神病学协会诊断和统计手册(DSM-5)。CHR-P主要影响青年 以及表现出多种症状的年轻人，包括减弱的阳性症状(妄想症和 幻觉)，令人痛苦，影响日常活动。 迫切需要临床试验来开发特效和安全的治疗方法，以减轻患者的阳性症状 慢性阻塞性肺疾病患者。然而，设计和资助这些所需试验的一个障碍是缺乏 FDA合格的临床结果衡量标准，用作评估疗效的主要结果。 一种新的测量减弱的阳性症状严重程度的仪器，被称为心理学，已经被 最近作为国家卫生研究院资助的加速药物基金会的一部分开发 合作精神分裂症观察性研究。这项研究旨在为未来的临床试验做准备。 支持中国药品监督管理局的药品注册。心灵协调了两种广泛使用的现有乐器 田野。一份追求精神病患者资格的意向书已被FDA视为可审查的。这个 下一步是制定资质计划。当前应用程序的目标是开发一种 全面和强大的临床评估结果合格的心理计划。当前项目 将通过以下方式加快资格计划的制定：a)通过一系列 电话会议和会议；b)吸收学术专家、患者和分析资源，使之系统化 目前的证据支持心理的概念适合性；以及c)进行初步定性 研究以帮助开发资格认证计划的内容有效性部分。

Abstract The clinical high-risk syndrome for psychosis (CHR-P) is a common psychiatric condition identified in the American Psychiatric Association’s Diagnostic and Statistical Manual (DSM-5). CHR-P primarily affects youth and young adults who exhibit multiple symptoms, including attenuated positive symptoms (delusions and hallucinations) that are distressing and impairing of daily activities. Clinical trials are urgently needed to develop specific and safe treatments for attenuated positive symptoms in CHR-P patients. An obstacle to the design and funding of these needed trials, however, is the absence of an FDA-qualified clinical outcome measure for use as the primary outcome upon which efficacy is assessed. A new instrument to measure the severity of attenuated positive symptoms, called the PSYCHS, has been recently developed as part of Foundation for the National Institutes of Health-funded Accelerating Medicines Partnership Schizophrenia observational study. The study is designed to prepare for future clinical trials supporting drug registration in CHR-P. The PSYCHS harmonizes two existing instruments extensively used in the field. A letter of intent to pursue qualification of the PSYCHS has been deemed reviewable by the FDA. The next step is to develop a Qualification Plan. The objective of the current application is to develop a comprehensive and robust clinical assessment outcome Qualification Plan for the PSYCHS. The current project will accelerate development of the Qualification Plan by: a) obtaining FDA input through a series of teleconferences and meetings; b) engaging academic experts, patients, and analytic resources to systematize current evidence supporting the conceptual suitability of the PSYCHS; and c) conduct preliminary qualitative studies to help develop the content validity section of the Qualification Plan.