Electronic clinical trial protocol distribution via the World-Wide Web: a prototype for reducing costs and errors, improving accrual, and saving trees

Abstract

Clinical trials today typically are inefficient, paper-based operations. Poor community physician awareness of available trials and difficult referral mechanisms also contribute to poor accrual. The Physicians Research Network (PRN) web was developed for more efficient trial protocol distribution and eligibility inquiries. The Medical University of South Carolina's Hollings Cancer Center trials program and two community oncology practices served as a testbed. In 581 man-hours over 18 months, 147 protocols were loaded into PRN. The trials program eliminated all protocol hardcopies except the masters, reduced photocopier use 59%, and saved 1.0 full-time equivalents (FTE), but 1.0 FTE was needed to manage PRN. There were no known security breaches, downtime, or content-related problems. Therefore, PRN is a paperless, user-preferred, reliable, secure method for distributing protocols and reducing distribution errors and delays because only a single copy of each protocol is maintained. Furthermore, PRN is being extended to serve other aspects of trial operations.

Figure 1

PRN Production System Components. Workstations running Web browsers (e.g., Netscape Navigator, Microsoft Internet Explorer) have high-speed campus Ethernet access or slower dial-up access (via the Xylogics MicroAnnex remote communications server) to the PRN Web, comprised of identically configured, Intel Pentium-based primary and “hot spare” backup servers from Dell (on different subnets) running O'Reilly & Associates' WebSite as a Web server package on top of Microsoft Windows NT 3.51. Octopus Technologies' Octopus package keeps the backup protocol database in sync with the primary one. If the primary server fails, Octopus immediately switches the backup into service; users' access to PRN is affected only by workstation, workstation subnet, or backbone failures, not by server or server subnet failures.

Figure 2

Protocol Loading Process. Protocol hardcopy is fed through an Envisions Env24Pro scanner. Scanned images of text are converted by the Optical Character Recognition process into text, after which editing tools are used to correct OCR errors and insert HyperText Markup Language (HTML) coding to instruct the browser how to display the text. HTML coding includes hypertext linking of all of the protocol's internal references (e.g., literature references, “See section...” references, etc.). Graphics are handled separately from text. Each graphic image's resolution is reduced to a reasonable lower limit of readability to decrease downloading time when the image is being retrieved through a (relatively low-speed) dial-up connection to the Internet. Graphics are stored (separately from their associated HTML pages) in Graphics Interchange Format files, displayable by all graphics-capable Web browsers. The HTML pages reference the GIFs as in-line graphics so that, when the page is displayed, associated graphics are automatically shown, too. In the PRN web, each protocol section comprises a single HTML page regardless of the section's hardcopy length. A protocol's HTML pages and GIF files are stored in a unique directory allocated for the protocol in the Windows NT file system. The protocol “database” is this set of protocol directories. Protocol indices, including the full-text search index, are updated after a protocol has passed review.

Figure 3

PRN trial eligibility inquiry process.

Figure 4

Protocol accesses per week.