Nextrials Simplifies Trial Management with EDC

By M.L. Baker  |  Posted 06-21-2005
PHILADELPHIA—Nextrials, a software and services company for managing clinical trials, announced Monday that its products are now integrated with those for conducting and collecting data for trials.

The arrangements were finalized over the past few weeks and include Dynarand LLC, Covance Inc., Cardinal Health Inc., Fisher Clinical Services Inc. and Acculogix Inc. For Covance, data can be delivered using CDISC (Clinical Data Interchange Standards Consortium), a platform-independent clinical data transfer standard regarded favorably by the FDA.

Nextrials Inc.'s software moves data into a single, centralized system from several vendors specializing in interactive voice response, central laboratory and drug distribution. These vendors are used widely by the industry to gather information about how a drug is working.

That means a company sponsoring clinical trials can know quickly whether its agents have enrolled enough patients in a study and are collecting data appropriately.

The announcement came in Philadelphia at the annual meeting of the Biotechnology Industry Organization, which drew some 18,000 biotech executives this year.

The ability to interact with Covance was one of the software's major attractions, said John Ferraro, associate director of clinical operations at GlobeImmune Inc. His company is using Nextrials for an early-stage clinical trial in hepatitis C. Patients in the trial are monitored at five different sites: Miami, New York, Denver, Chicago, and Pasadena, Calif.

For GlobeImmune's first clinical trial, in cancer, the company used paper forms to collect data. For its second trial, in hepatitis, it decided to go electronic, and has decided to use EDC (electronic data capture) for every subsequent trial.

Read details here about a Medicare database that could track drug safety.

"It helps us to follow the study from a distance in real time," Ferraro said. For the hepatitis trial, Ferraro can monitor progress daily. For the paper-based cancer trial, he said, he has to wait 45 days. Faster reporting helps make sure the trials are conducted safely and accurately.

For example, if results from one site are different from results at another, Ferraro can quickly investigate to find out if clinical trial monitors are following the trial appropriately.

Ferraro said that he interviewed about six EDC companies extensively before settling on Nextrials. At least one software vendor was eliminated because it would require GlobeImmune to hire IT personnel to maintain servers on-site. Others didn't allow the Internet to be used as middleware.

Ferraro said he also wanted to work with a company that served small to midsized companies. He said he had worked with larger EDC companies when he was at Pfizer Inc., the world's largest drug company, which runs trials enrolling thousands of patients. "If we went with a larger EDC company, we wouldn't be on their radar screen with our small study," he said.

Instead, Nextrials tailored some software directly to GlobeImmune's needs. "We've thrown some challenges at them, and they think about it, and a week later, there it is," said Ferraro.

For example, GlobeImmune planned to conduct a so-called dose escalation study, in which patients start taking a low dose of a drug and gradually move up to larger doses.

These trials can be logistical nightmares: Different doses may require different procedures, and, because patients enroll at different times, patients at one site may be receiving several different doses.

"We wanted to build a waiting list, so that as patients are screened, they're queued up for the next dosing level when it's available," Ferraro said. The list also has to be available to all sites, he said, and Nextrials made it possible.

Nextrials CEO James Rogers said the company's software not only collects and aggregates data, it can be used to drive project management.

Click here to read about a nationwide health-data sharing experiment.

For example, drug sponsors usually reimburse sites for a variety of activities, such as enrolling patients, drawing blood, conducting exams and other activities. The software not only tracks whether a trial site is on schedule, it can also generate invoices and reminders.

But Rogers has grander plans as well. He said he thinks the software can serve as an in silico version of a safety monitoring committee.

Rogers said this year was the first that company executives had attended BIO, the world's largest biotechnology conference. He said that several companies had already approached him about future partnerships, including contract research organizations and one that manages clinical samples.

To guard against bias, drug company executives are typically allowed to see results only at limited, predesignated points in a clinical trial. A panel of independent experts regularly inspects results in progress to decide if the trial plan should be changed.

If patients receiving the experimental drug show marked improvement over patients receiving standard treatment, the experts can advise that all patients receive the experimental drug. Conversely, if patients experience no benefit or undue side effects, the experts can recommend stopping the trial early.

However, compiling the data and convening the expert committee can take weeks and even months. Even then, the data is often incomplete.

Nextrials plans to incorporate safety monitoring into the system, through yet another collaboration that will allows its software to map specific adverse events. This could slash the administrative headaches involved in convening experts, plus generate alerts if experts should meet earlier than planned.