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

DDT-COA-000-163 作为 ClinRO 措施，加快 PSYCHS 的 FDA COA 资格计划

• 批准号: 10836892
• 负责人: Catalina Valerie Mourgues-Codern
• 金额: $ 24.98万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-15 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10836892
• 关键词: DDT; COA; 000; 163; Accelerating

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.

抽象的 精神病临床高危综合征（CHR-P）是一种常见的精神疾病，在 美国精神病学协会的诊断和统计手册 (DSM-5) 主要影响青少年。 以及表现出多种症状的年轻人，包括减弱的阳性症状（妄想和 幻觉）令人痛苦并损害日常活动。 迫切需要进行临床试验来开发针对减轻阳性症状的特异性和安全的治疗方法 然而，CHR-P 患者的设计和资助这些所需试验的一个障碍是缺乏 FDA 合格的临床结果测量可用作评估疗效的主要结果。 一种测量减弱阳性症状严重程度的新工具，称为 PSYCHS，已被开发出来。 最近作为美国国立卫生研究院资助的加速药物基金会的一部分开发 该研究旨在为未来的临床试验做准备。 支持 CHR-P 中的药物注册。 PSYCHS 协调了两种常用的现有工具。 寻求 PSYCHS 资格的意向书已被 FDA 视为可以审查。 下一步是制定资格计划当前申请的目标是制定一个资格计划。 当前项目的全面且稳健的临床评估结果 PSYCHS 资格计划。 将通过以下方式加速资格计划的制定： a) 通过一系列的措施获得 FDA 的意见 b) 吸引学术专家、患者和分析资源进行系统化 支持 PSYCHS 概念适用性的当前证据；以及 c) 进行初步定性； 研究以帮助制定资格计划的内容有效性部分。