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 临床高危综合征（CHR-P）是一种常见的精神病疾病 美国精神病学协会的诊断和统计手册（DSM-5）。 CHR-P主要影响青年 和暴露了多种症状的年轻人，包括肿瘤症状减弱（妄想和 幻觉）令人沮丧和损害日常活动。 迫切需要进行临床试验，以开发特定和安全的治疗方法，以减轻阳性症状 CHR-P患者。但是，这些所需试验的设计和资金的障碍是没有 FDA符合条件的临床结局指标作为评估有效性的主要结果。 一种测量衰减阳性症状严重程度的新工具，称为心理，已经是 最近开发的是美国国立卫生研究院基金会的一部分 伙伴关系精神分裂症观察研究。该研究旨在为将来的临床试验做准备 支持Chr-P中的药物注册。心理统一了两种现有的工具广泛使用 领域。 FDA认为可以审查购买心理资格的意向书。 下一步是制定资格计划。当前应用的目的是开发 心理的全面且强大的临床评估结果资格计划。当前项目 将通过以下方式加速资格计划的制定 电信和会议； b）参与学术专家，患者和分析资源以系统化 当前支持心理概念适应性的证据； c）进行初步定性 研究有助于制定资格计划的内容有效性部分。