Clinical Trials: The Internet is Coming!

Computers have revolutionized the way clinical trial data is collected and processed, but early attempts to turn mountains of paper reports into manageable computer files did little more than eliminate paper. Although paperless reporting remains a worthy goal (ask anyone who processed data the old way), it barely scratches the surface of possibilities available today through global networking.

Real-time information can be critical in operating a clinical trial, especially when data is pouring in from multiple centers around the world. In some cases clinical studies have been cut short—or for life-threatening illnesses the placebo arm discontinued—when the data dictated it.

Remote entry for the reams of data generated during clinicals has been around for several years. The driving force was (and remains) obtaining cleaner data, faster. Through an early implementation sponsors lent investigators a laptop computer loaded with proprietary software. Data was entered into the computer as it was generated. At the end of the trial the investigator shipped the computer back to the sponsor, who uploaded data onto a central computer for processing.

Internet and World Wide Web technology takes the clinical trials industry several steps beyond replacing paper notebooks with silicon. Today, all that's required to participate in Internet-based clinical trials reporting is an Internet connection, a Web browser, and a central computer (server) equipped with the right data collection software.

"Web technology takes us a step farther than the old laptop-centered data collection," says Daniel Perich, VP of Marketing at Domain Pharma Corp. (Lexington, MA). Domain provides client software and related services enabling web-based collection of clinical trial data. Reducing end-user software and hardware requirements to those of a casual Web saves considerable costs while opening up the possibility for real-time data acquisition and processing. "In terms of user technology, most folks are web-literate," Perich told Pharmaceutical Online. "Using web-based software comes naturally to them."

Perich puts human factors on par with technology as the principal barriers to adopting the Web for reporting clinical data. "End users and sponsors have to shift their work paradigm, work processes, and workflow; the way they produce and handle information. It's as much a people issue as a technology issue."

Regulatory issues and data integrity may also slow the implementation of Internet-based clinical reporting. "Regulations right now are ambiguous," Perich said. "Documentation must follow 21 CFR Part 11, which covers documentation. Users are also concerned about security." But Perich sees regulation and security as minor hurdles. "These issues are largely addressable. They're details."

Another factor affecting how rapidly clinical centers move to Web-only reporting is Internet access. Perich believes that today, 75% of clinical centers could do all their reporting through the web, versus 10% (his estimate) that are actually doing it. "Not every country today has the Internet infrastructure that's needed right now to implement Web-based reporting, but that's changing rapidly. Eventually virtually all clinical sites will be wired."

Perich's firm, Domain Pharma, sets itself apart from other developers of Web-based clinical reporting software by recognizing that not everyone will instantly move all aspects of a trial to electronic format. "Most trials today are paper-based. As this idea gains momentum, investigators will want to mix paper and electronic paradigms, sometimes within the same trial. We facilitate that. Our products can handle any part of the paper-to-internet spectrum: all paper, mixed, or all electronic. That's very different from the all-electronic products offered by our competition."

Domain's back-end Web-enabling reporting software doesn't yet have a name. A standalone product, Clintrial 4, provides clinical data management for trial design, entry of paper-based forms in the paper paradigm, query management and tracking, data visualization and analysis tools.

At the 35th Annual Meeting of the Drug Information Association in Baltimore on June 28, Domain demonstrated the latest versions of Clintrial 4 and another product, Clintrace. Improvements include extensions, for Web-based reporting, that will initially supplement the existing Clintrial 4 product portfolio, permitting the use of both paper and electronic case report forms in the same clinical trial. These new applications will be expanded over time to create a complete Web-based solution for clinical trials, providing full functionality for sponsor companies, clinical research organizations, and clinical investigators. Web technology will also be the foundation of Domain's open platform strategy and architecture for interfacing to user-developed and third-party software applications within the clinical trials arena.

Domain Pharma believes its approach goes beyond existing remote data entry products for clinical trials in that it integrates key capabilities, minimizes remote client system administration, and eliminates redundancies currently required for the use of such products. Case report forms and data checks will only need to be designed once for use with both paper-based and electronic trials. Data entered at investigator sites via the new Web applications will be managed more quickly and directly by the sponsor or CRO, rather than require further processing and subsequent transfer from system to system.

At the same meeting Clinicor, Inc. (Austin, TX) launched CorDat@, a web-enabled application for accessing real-time updates on clinical research trials in progress. CorDat@ is an integral part of every new Clinicor study, allowing product development trial sponsors to log onto a secure extranet and view real-time project updates on patient enrollment, project management, clinical data management, and financial project status, including investigator payments.

CorDat@, which is Y2K compliant, operates on a single database platform accessible through a secured website. According to Clinicor President Robert S. Sammis, CorDat@ enhances his company's clinical information technology capabilities. "Sponsors have told us they are interested in having access to information tools like CorDat@ to allow them to efficiently monitor the progress of their clinical trials in real-time. CorDat@ gives our clients the control they want over their clinical trials, and the power to quickly identify any issues in order to implement proactive solutions immediately."

As a contract research organization, Clinicor provides clinical development services including Phase I–IV clinical trials management, patient recruitment, monitoring, data management services, and regulatory consultation to the pharmaceutical, biotechnology and medical device industries. Clinicor differentiates itself through a unique operating model that emphasizes its specialized patient recruitment, patient management and study monitoring capabilities. Clinicor accelerates patient recruitment and enhances the accuracy of clinical data, resulting in high caliber clinical trial services offering significant value to sponsors.

PhaseForward Inc., (Waltham, MA) announced at the Drug Information meeting that Covance Inc. (Princeton, NJ) will license Phase Forward's InForm Web-based clinical trial data collection and management software as a key element of Covance's clinical research and clinical support services. The agreement includes joint product development, joint marketing, education and training, and support initiatives.

Completely XML-based, InForm is currently being used in clinical trials worldwide. Covance will use it to improve the quality and capacity of Phase I–IV clinical trials. In addition, Covance and PhaseForward will work on providing a common access to the data generated by Covance's other core clinical support services such as central laboratory services, centralized ECG, and clinical packaging. This single Internet-based data conduit will convey clinical trial data, CRF data, lab data, etc. under a common user presentation to investigators, monitors, and clinical trial scientists at pharmaceutical companies. Both companies believe InForm will reduce the cost of user training and provide access to the key information that will give pharmaceutical companies visibility and control of the data and significantly enhance the efficiency of their clinical trials.

With InForm, sponsors of clinical trials can access clinical trial data in real-time, and begin data analysis almost immediately after the last patient has visited the clinic. By eliminating the need to transcribe and process traditional paper data forms, clinical trial sponsors can accelerate the delivery of new and beneficial drugs and medical devices to market, and maximize their revenue potential.

PhaseForward also announced a collaboration with British Telecommunication plc (BT; London) focusing on the challenge of eliminating the paper trail faced by clinical researchers. The two companies will pioneer a fully managed network-based reporting system in Europe that they hope will give trial sponsors a real-time, quality controlled view of all their trial data.

Tony Kane, BT's business manager for pharmaceuticals, believes that the BT/Phase Forward alliance will transform the clinical trial process to make it more effective, ultimately reducing time to market. "The pharmaceutical industry has long needed a data system which can keep pace with the productivity pressures of drug development and so boost the product launch rate from a typical 0.5 per year to the 4–5 per year that analysts suggest is the requirement to sustain shareholder value. Paper-based reporting for clinical trials is no longer adequate or appropriate for today's fast-moving trials environment—and that is where our proposition will revolutionize this marketplace. This is the first step for BT in a major push that will see us work with leading partners across the clinical trials industry to provide a truly one stop shop for handling data."

For more information: Daniel Perich, Domain Pharma Corp., 10 Maguire Rd., Suite 110, Lexington, MA 02421. Tel: 781-778-3700. Fax: 781-778-3800. James W. Clark, Jr. Chief Financial Officer, Clinicor Inc. Tel: 512-344-3300. Email: jim.clark@clinicor.com. Karen Wills, PhaseForward Inc. Tel: 781-890-7878. Fax: 781-890-4848. Email: karen.wills@phaseforward.
com.

By Angelo DePalma