東華大學圖書館 |

Language: English

Help

回圖書館首頁

手機版館藏查詢

Back

Switch To: Labeled | MARC Mode | ISBD

Development of a Web-based clinical ...

Franciosi, Luigi Giuseppe.

Linked to FindBook

Google Book

Amazon

博客來

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

Record Type:	Electronic resources : Monograph/item
Title/Author:	Development of a Web-based clinical trial protocol authoring system./
Author:	Franciosi, Luigi Giuseppe.
Description:	257 p.
Notes:	Source: Dissertation Abstracts International, Volume: 64-11, Section: B, page: 5466.
Contained By:	Dissertation Abstracts International64-11B.
Subject:	Health Sciences, Pharmacology. -
Online resource:	http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=NQ85444
ISBN:	0612854442

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

Development of a Web-based clinical trial protocol authoring system. - 257 p.

Source: Dissertation Abstracts International, Volume: 64-11, Section: B, page: 5466.

Thesis (Ph.D.)--The University of British Columbia (Canada), 2003.

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.

ISBN: 0612854442Subjects--Topical Terms:

1017717
Health Sciences, Pharmacology.

Development of a Web-based clinical trial protocol authoring system.
LDR:03537nmm 2200301 4500 001 1864178
005 20041216131313.5
008 130614s2003 eng d
020 $a 0612854442
035 $a (UnM)AAINQ85444
035 $a AAINQ85444
040 $a UnM $c UnM
100 1 $a Franciosi, Luigi Giuseppe. $3 1951687
245 1 0 $a Development of a Web-based clinical trial protocol authoring system.
300 $a 257 p.
500 $a Source: Dissertation Abstracts International, Volume: 64-11, Section: B, page: 5466.
500 $a Adviser: Bernard A. MacLeod.
502 $a Thesis (Ph.D.)--The University of British Columbia (Canada), 2003.
520 $a 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.
520 $a 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.
520 $a 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.
520 $a 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.)
590 $a School code: 2500.
650 4 $a Health Sciences, Pharmacology. $3 1017717
690 $a 0419
710 2 0 $a The University of British Columbia (Canada). $3 626643
773 0 $t Dissertation Abstracts International $g 64-11B.
790 1 0 $a MacLeod, Bernard A., $e advisor
790 $a 2500
791 $a Ph.D.
792 $a 2003
856 4 0 $u http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=NQ85444