Clinical Research Technology News (Winter 1998)

In this column of the special Technology Issue, we are providing our readers with news on recent developments in clinical research technology. Contact numbers are given where possible. This information has been gathered by the Editor to the best of his knowledge at time of publication. For more details, call the companies mentioned.

The most exciting developments in clinical research technology in 1998 are likely to revolve around the use of the Internet, as people experienced in clinical research apply their expertise to use the Internet in appropriate ways. The Web is already playing a role in patient recruitment and investigator identification, led by CenterWatch and others. There are several new initiatives underway in Web-based trials management and electronic data collection (EDC). Some are just ideas, others have been released, and at least one company is backed by major funding wth significant plans which show great promise. It’s early days, but this picture should begin to become clear by the March DIA meeting on clinical data management in Philadelphia and the ACRP Annual Meeting in May.

At the Executive Retreat on Technology in October, Anderson Clinical Technologies showed an innovative, low-cost patient diary system based on their punch-card technology used for drug compliance; (847) 392-9190.

AVANTEC continues to enhance its already comprehensive service offering for collecting and managing data electronically. It has added a significant new suite of trials management tools to its overall service offerings; (800) 574-8610.

Battelle and Boston Healthcare Associates have formed a joint venture to create a clinical data warehouse based on the cooperative pooling of data from major managed care organizations and health systems. This could have a significant impact on outcomes research (617) 912-5170.

Domain Solutions has announced the long-awaited release of Clintrial 4.1. ClinTRACE is claimed to be the leading Adverse Event system in terms of number of customers. The Clintrial 4 development partners report slow going in the transition to the new product. Meanwhile the company has seen significant executive management turnover, and is in the process of ongoing consolidation following the absorption of Presidio (an EDC vendor); (919) 547-7070.

DLB Systems has been acquired by Premier Research Worldwide, a publicly held CRO. Coincident with this has been the strengthening of the company’s management team with new players. Premier’s financial strength, CRO services, and longstanding expertise in collection and submission technologies make the Premier/DLB combination unique. DLB’s Web-based site entry solution is being beta tested for formal release later in 98; (800) 879-0352.

IBM is making news with its new partnership with PPD Pharmaco’s Belmont Research unit. IBM will be reselling Belmont’s software products and Belmont will be working on extending IBM ClinWare beyond EDC and trials management. IBM is reported to be making inroads at major pharmaceutical companies with its EDC product to challenge TechniLogix (see below) for the leading EDC position. Glaxo Italy had reported it is piloting a Web version of ClinWare. IBM also supports the DataTRAK services company through providing ClinWare software, hardware support and network connectivity through the IBM Global Network; (617) 895-2834.

TechniLogix, Inc., an EDC vendor, now claims almost 3000 sites are current users of their Quest software in active trials. At least 4 major pharmaceutical companies are using their software in multiple, multisite, global trials and the company remains the only EDC vendor with practical experience in multinational Phase III trials of any real scale; (201) 840-1212.

The pharmaceutical unit of SAIC (Science Applications International Corporation), the country’s largest employee-owned technology company, has completed two important projects this year: it has ported its patient recruitment system (a robust Oracle-based system with call center support) to Windows NT for an SMO, and it is completing the first full-featured EDC system built in SAS, this for a pharmaceutical company; (937) 431-2261.

Viacron Inc, a disease management technology firm, has an FDA-approved device which could be applied to patient diaries. It may be the best combination of low cost, interactive communication between study coordinator and patients, and sophisticated graphical reports of any other offering; (612) 920-1651.

Site-specific software remains an underserved market. Advanced Clinical Software has a new version of Study Manager and a new service called E-Trial; (206) 230-8225. Integra Systems Design has been developing a significant product now in testing; (334) 433-4400. Premier/DLB is exploring how its Field Monitor product could be better adapted to site-specific uses; (800) 879-0352.

Vision Quest

This year, 1997, may be a turning point for clinical research technology, much as it is for technology in general. In the information technology marketplace, the twin impact of falling hardware prices and hyper-attention on the Internet is changing the way some companies view the role technology can and should play in their enterprise. We in clinical research look at these same trends and wonder what potential advantage may be in the offing lower costs, greater efficiencies, realization of long-delayed promises?

The possibility of the new is juxtaposed to the failing of the old. Familiar software vendors in the clinical research marketplace are weakening, merging, or failing. These failures reflect the nature of our marketplace: clinical research is specialized enough, and yes, small enough, that product vendors cannot profitably survive. Only integrators or custom developers, carefully managed, can really provide the value solution clinical research customers require. “Off-the-shelf” software can be enormously valuable; what we need to figure out is how to nourish those companies of value sufficiently to ensure their building blocks are available for us.

New companies are emerging, which may represent real value or may simply be instruments of new technology the Internet “hammer” looking for some “nails” to hammer flat. The test of real value ultimately lies with us, the users and designers of systems which enable clinical research to be done faster, more efficiently, with better quality.

In this turmoil, we need vision to bring us to a useful path. Vision can come from us, or from the vendors, or perhaps from both in concert. Vendors in our industry for the most part have been consistently technology-driven, rather than product-driven, meaning that users need to work hard to adapt their products to their particular real-life situations. New technologies like the Internet, or groupware, or Java, mean more product “push” and less application “pull”.

The best assurance that your use of technology will be successful is the creation of a pragmatic, comprehensive vision of what the value of your business or function is, how it needs to evolve in the next decade, and the right tools to realize that vision.

Some pharmaceutical service organizations are beginning to demonstrate the creative and useful implementation of technology for their customers. Some CROs and SMOs already have, or are in the process of implementing, strategies which will help with inter-company communications, timely status reporting, patient recruitment, document retrieval and transmission, and the collection and cleaning of clinical data.

Research sponsors are also slowly beginning to realize that they have a responsibility to lead the process of improving clinical research for all. Bringing electronic data collection or clarification tools to the site community is a good beginning. Much hard work has gone into international standardization efforts, and the FDA’s leadership has been invaluable in the U.S. in ensuring that technology can accelerate the submission and review process. What we need is a parallel effort to reduce the enormous inefficiency in the industry where each company (and each department in each company) has its own, distinct, immutable ways of collecting essentially similar or identical data for each trial.

An industry vision, rather than a vendor vision or a company vision, might be helpful. An example which we are beginning to discuss is the creation of a “Clinical Data Utility” a means by which today’s more ubiquitous wide-area networking, less expensive hardware, easier connectivity, and appropriate software functionality could be combined into a universal service for gathering and cleaning clinical data from investigative sites. This could provide efficiencies at least as powerful as what we are beginning to see in electronic submissions, and significantly improve the operations of all participating investigative sites.

A clinical data utility is just one example of the greater vision we need in applying technology to the clinical research process. All of us have the potential to contribute, in a year of technology turmoil.