Computerized Antipsychotic Evaluation System

描述(由申请人提供)：广泛的神经认知评估是候选抗精神病药物治疗受控临床试验的组成部分。然而，人工管理大型神经认知测试电池效率低、容易出错、成本相对较高，并且不能满足制药行业向计算机化临床试验实施过渡的需求。该项目的目标是开发一种先进的、广谱的计算机化神经认知评估系统，该系统提供一个单一、统一的平台来管理各种方案，并赋予现代信息技术的优势，以实施和管理临床试验和相关研究方案。计算机化的优势包括：通过标准化管理提高数据质量；自动化项目报告和文件编制；自动化患者跟踪和日程安排；自动化方案遵从性；减少审查员要求和错误；自动生成和跟踪CRF；自动化电子数据库传输和降低成本。总体来说，计算机化的管理将降低实施临床试验的成本。该计算机平台将独一无二地适用于对受损科目的评估，因为其交互式双显示和控制架构集成了一名人工审查员。这使得考官能够对口头报告和公开的行为表现进行评分，否则使用单一显示系统是不可能的。为了确保评估仪器电池和系统功能在临床试验中应用的相关性，拟议的硬件-软件组合将与精神分裂症研究领域公认权威的指导委员会合作开发，其中包括NIMH赞助的CATIE(干预有效性临床抗精神病试验)联盟的成员。在第一阶段，将在人类患者样本中确定原型系统的一组代表性测试仪器的技术实用性和同时有效性。

DESCRIPTION (provided by applicant): Wide-ranging neurocognitive assessment is an integral component of controlled clinical trials of candidate antipsychotic treatments. However, manual administration of large neurocognitive test batteries is inefficient, error prone, relatively costly and does not meet the needs of the pharmaceutical industry as it transitions to computerized clinical trial implementation. The project objective is to develop an advanced, wide spectrum computerized neurocognitive assessment system that provides a single, unified platform for administration of various protocols, and confers the advantages of contemporary information technologies for implementation and management of clinical trials and related research protocols. Advantages of computerization include: increased data quality through standardized administration; automated project reporting and documentation; automated patient tracking and scheduling; automated protocol compliance; reduced examiner requirements and errors; automatic generation and tracking of CRFs; automated electronic database transfer and reduced costs. Computerized administration will, overall, reduce costs to implement clinical trials. The computer platform will be uniquely suited to assessment of impaired subjects due to its interactive dual-display and control architecture which integrates a human examiner. This enables an examiner to score verbal report and overt behavioral performance otherwise not possible with single display systems. To ensure relevance of the assessment instrument battery as well as system functions for application in clinical trials, the proposed hardware-software ensemble will be developed in collaboration with a steering committee of recognized authorities in the field of schizophrenia research, including members of the NIMH sponsored CATIE (Clinical Antipsychotic Trials in Intervention Effectiveness) consortium. In Phase I, the technical utility and concurrent validity of a representative set of test instruments of a prototype system will be determined in a sample of human patients.