Clinical Interview Data Acquisition System

描述（由申请人提供）： 实施临床试验以评估新的治疗方法涉及收集和处理大量的患者数据。目前，在临床试验中收集的所有主要患者数据中，超过90%是使用纸质表格记录的，因此造成了许多根本的效率低下和成本。临床试验的计算机化在很大程度上仅限于登记跟踪和各种数据库处理操作。医生管理的结构化访谈和评级过程的计算机化采集更加复杂，特别是对于需要输入多种数据类型（例如书面文本、模拟量表、复选框）的评级量表。 该项目的目标是开发一种解决方案，在临床试验中，在接触点实现患者访谈过程的计算机化。拟议的系统将是第一个在面对面的临床评估访谈中取代纸质表格的系统，支持多种数据类型的输入，并标志着将几种新技术引入抗痴呆化合物的对照临床试验，包括平板电脑。计算机化的优点包括：立即以电子方式记录书面面谈叙述;通过一个功能强大、完全相关的数据库，以计算机为基础审查和灵活查阅储存的电子表格;自动生成病例报告表;以及自动化项目报告和文件编制。临床访谈数据采集系统将包括标准化评估访谈工具以及辅助软件实用程序，以协助实施和管理临床试验，包括符合FDA指南要求的临床试验。在第一阶段，系统的可比性、技术实用性和用户可接受性将在模拟和现场患者访谈中确定。

DESCRIPTION (provided by applicant): Implementation of clinical trials to assess new treatments involves collection and processing of formidable amounts of patient data. Currently, well over 90% of all primary patient data collected in clinical trials is recorded using paper forms, thus imposing numerous fundamental inefficiencies and costs. Computerization of clinical trials has been largely limited to enrollment tracking and various database processing operations. Computerized acquisition of physician-administered, structured interview and rating processes is more complex, especially for rating scales that require entry of multiple data types (e.g. written text, analog scales, check boxes). The project objective is to develop a solution for computerization of the patient interview process in clinical trials at the point of contact. The proposed system would be the first of its kind to replace paper forms in face-to face clinical rating interviews, support entry of multiple data types and mark the introduction of several new technologies into controlled clinical trials of antidementia compounds, including the tablet PC. Advantages of computerization include: immediate electronic capture of written interview narrative; computer-based review of and flexible access to stored electronic forms through a powerful, fully relational database; automatic generation of case report forms; and automated project reporting and documentation. The clinical interview data acquisition system will include a standardized assessment interview instrument as well as ancillary software utilities to assist implementation and management of clinical trials, including those required to meet FDA guidelines. In Phase I, the comparability, technical utility and user acceptability of the system will be determined in both simulated and live patient interviews.