UBC Theses and Dissertations

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UBC Theses and Dissertations

Development of a web-based clinical trial protocol authoring system Franciosi, Luigi Giuseppe


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 webbased expert authoring tool. Once the advisory module was completed, it was evaluated together with PGM as the complete PAS prototype in a small group of subjects. Preliminary results suggest a significant improvement in design and statistical detail of PAS protocols as compared to textbook protocols. PAS has been formulated, developed and evaluated in a manner that makes it significantly different from other computer tools used for clinical trial planning. The findings of this dissertation demonstrate that PAS significantly improves the ability of novices to produce clinical trial protocols that meet GCP requirements.

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