(Below is the Column from the Fall issue, October 1996)

Information Technology in Clinical Research

Welcome to the first of a new column for Monitor, on the use of information technology in clinical research. The overall theme of this series is that “empowerment through technology will be the hallmark of successful research enterprises in the coming decade.” The strong attendance at the Technology Track sessions at the ACP Annual Meeting in May, and the breadth of technology offerings in the Exhibit Hall of the DIA Annual Meeting in June, are reflections of the acceleration in applying technology to the process of clinical research.

Information technology can significantly contribute to all phases of clinical research, from protocol design to data collection, from data management to adverse event reporting, from analysis to project management. While technology innovations have focused in the past on what the sponsor is doing with the data, an increasing emphasis by vendors and sponsors alike is now being placed on the use of computers at the investigative site — collecting the data, monitoring site progress, facilitating patient recruitment, linking sponsor and investigator.

ACP Technology Track

A look at the Annual Meeting’s Technology Track will give you a sense of the widespread use of technology in research today. We heard speakers from Zeneca and Astra Merck talk about the use of electronic data collection (EDC) in clinical trials. We heard from research sites and investigator networks who are taking a wide range of approaches (from outsourced fax services to custom applications networks) to using computers for data collection and patient tracking. Corning SciCor described how to link electronically centralized laboratory data with sponsor and site clinical data.

We saw a new technology for patient diaries, and heard about remote physiologic monitoring, which could lead to the day when patients won’t have to come in to the site at all. We heard how groupware can be used for adverse event reporting and patient tracking, and how the Internet can be used for patient recruitment, data collection and project management. There are even computer applications very specific to clinical research: a service providing a nationwide database of investigator sites, and software designed to help sponsors monitor the quality of trial conduct on a site-by-site basis.

A Mixed Blessing

In some cases, the push towards using technology has been confusing and a burden for investigative sites. John Raines provided a checklist to sponsors on what not to do when trying to bring a new computer tool to a site. Some investigators already face the dilemma of several computers in their office, each from a different sponsor using different software. One step toward resolving this problem will be greater cooperation among vendors and the establishment of standards, where possible. This process may have begun at the Annual Meeting, where a panel of major EDC vendors met together for the first time.

One possible response to the influx of technology from your customers is to position your site as an experienced user of your own technology solutions. This is likely to be an important source of competitive advantage in the coming years, and will be the topic of a future column.

The good news in technology these days is that despite (or is it because of?) the flood of new technologies and expensive hardware, it is actually becoming easier to apply computers to everyday work. You and your staff are (willingly or not!) becoming more computer-savvy. New technology platforms, like Lotus Notes¢ç or Visual Basic¢ç, make it much easier to develop robust, highly usable applications. And the labor pool overall is increasingly skilled in programming and computer operations, at a lower cost.

DIA Annual Meeting

Those of you who were able to attend the DIA Annual Meeting in San Diego saw an impressive array of vendors in the Exhibit Hall. It is quite remarkable to see the change in the exhibits at this meeting just within the last few years. Notable new technology offerings were seen in the Pharos booth (a joint venture of Pharmaco and Telos) and at IBM, showing a new “Clinware” product line. Established vendors such as DLB, TechniLogix, BBN, Onsite and Presidio (formerly Penergy) all showed new releases with strong improvements in interface, usability and feature breadth. The Lotus booth showed the wide range of applications that can be built on groupware. Particularly impressive was how many investigative sites and small CROs were demonstrating valuable home-grown computer tools which prove the point that rapid application development is here and practical.

Understanding Process; Evaluating Vendors

Another future column will discuss the process of selecting and implementing new technologies. We’ll try to help you avoid the pitfalls which can occur when new software is introduced without sufficient analysis, planning and training. Before you buy your next software, you should have a good understanding of your primary business objectives, how you do your work today and where are the major sources of delay and cost, where technology can help and what the options are, and how to evaluate the vendors who will become important players in your business.

We’ll also take a look at specific new technologies as they are announced, and help you consider how they may apply to clinical research. For ACP members, the key areas for using technology in our work include, but are not limited to, electronic data collection, site monitoring, patient recruitment, project management, sponsor-site communications, adverse event reporting, patient diaries, laboratory data integration, patient charting, and more.

The most exciting aspect of technology in clinical research is how it can open the user to a wider world of intellectual reach and business impact. The more technologically sophisticated investigators and sponsors are positioning themselves to be the leaders in how new therapeutics are studied. Technology will begin to influence study design, and enable new kinds or extent of information to be gathered. The clinical data we gather will be used by an ever wider audience, beyond the immediate sponsor, and those who build or become familiar with the systems to capture, analyze and distribute this information will be called upon to perform tomorrow’s research.