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Development of a Web-based clinical trial protocol authoring system.

机译：开发基于Web的临床试验方案创作系统。

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摘要

A clinical trial is a planned, controlled and ethical experiment to evaluate the safety and effectiveness of a medical treatment in a patient population. Fundamental to a properly planned clinical trial is the protocol, which serves as a plan or set of instructions for trial conduct. Audits of past trials revealed that clinical trial protocols were either lacking sufficient detail, or non-existent. Reasons for these deficiencies include: a shortage of skilled clinical trialists, limited time and budgets to conduct proper planning of clinical trials, and negligible funding and logistical support for new trialists. Therefore, the purpose of this dissertation is to develop a new method that can improve the authoring of clinical trial protocols.; After an extensive review of the medical literature, a web-based clinical trial Protocol Authoring System (PAS) was designed, developed and evaluated. PAS is a computer program that directs novices through the development of a protocol for a randomised controlled trial (RCT) done according to highest standards, or Good Clinical Practices (GCPs). The first component of this system is the protocol generating module (PGM), which prompts users on the necessary details for conducting the clinical trial. It has an online knowledge-base that contains expert advice in the form of Help files, hyperlinks, static decision trees, and literature references. The system runs on a Linux operating system with an Apache web server, Oracle database, and an HTML-Java web interface. A 20-page draft protocol is produced that contains a scientific question, experimental design, statistics, ethical considerations and standard operating procedures.; To determine the effectiveness of PGM as a protocol generator, fifty subjects were randomised to either the module or a standard textbook on the fundamentals of clinical trials. According to expert ranking of protocols, subjects using the PGM module produced protocols that were significantly better than those generated with the textbook (P 0.01). However, many PGM protocols were still lacking important design and statistical details.; Because of these deficiencies, the second component of the system---an advisory module---was constructed. This module guides novices through the selection of appropriate design and statistics for their clinical trial. To develop this module, a clinical trial expert was first interviewed to acquire design and statistical knowledge in algorithmic form. One path of the expert algorithm was then encoded using a web-based expert authoring tool. (Abstract shortened by UMI.)
机译：临床试验是一项计划，控制和道德的实验，旨在评估患者群体中药物治疗的安全性和有效性。该协议是制定适当计划的临床试验的基础，该协议可作为计划或一组指导进行的临床试验。对过去试验的审计表明，临床试验方案要么缺乏足够的细节，要么不存在。这些缺陷的原因包括：缺乏熟练的临床试验人员，进行临床试验的适当计划所需的时间和预算有限，以及对新试验人员的资金和后勤支持微不足道。因此，本论文的目的是开发一种可以改善临床试验方案编写的新方法。在广泛审查医学文献之后，设计，开发和评估了基于Web的临床试验方案创作系统（PAS）。 PAS是一种计算机程序，可以指导新手制定根据最高标准或良好临床规范（GCP）进行的随机对照试验（RCT）的方案。该系统的第一个组件是协议生成模块（PGM），它会提示用户有关进行临床试验所需的详细信息。它具有一个在线知识库，其中以帮助文件，超链接，静态决策树和文献参考的形式包含专家建议。该系统在具有Apache Web服务器，Oracle数据库和HTML-Java Web界面的Linux操作系统上运行。编写了一份20页的协议草案，其中包含科学问题，实验设计，统计数据，道德考量和标准操作程序。为了确定PGM作为实验方案产生者的有效性，将50名受试者随机分为有关临床试验基础知识的模块或标准教科书。根据协议的专家评级，使用PGM模块的受试者所产生的协议明显优于使用教科书生成的协议（P <0.01）。但是，许多PGM协议仍然缺少重要的设计和统计细节。由于这些缺陷，因此构建了系统的第二个组件-咨询模块-。该模块可指导新手为临床试验选择合适的设计和统计数据。为了开发此模块，首先对临床试验专家进行了采访，以算法形式获得设计和统计知识。然后，使用基于Web的专家创作工具对专家算法的一条路径进行编码。 （摘要由UMI缩短。）

著录项

  • 作者

    Franciosi, Luigi Giuseppe.;

  • 作者单位

    The University of British Columbia (Canada).;

  • 授予单位 The University of British Columbia (Canada).;
  • 学科 Health Sciences Pharmacology.
  • 学位 Ph.D.
  • 年度 2003
  • 页码 257 p.
  • 总页数 257
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 药理学;
  • 关键词

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