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UBC Theses and Dissertations

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

Abstract

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

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