Internet-based solutions offer one way to sidestep the issue, and are causing a paradigm shift. "Now people are leveraging the Internet as another infrastructure to connect business processes together," says Glen de Vries, CTO of Medidata Solutions (www.mdsol.com).
When he and his colleagues founded Medidata in 1999 they determined "to treat the Internet as an infrastructure that is as consistent and pervasive as the telephone, and as comfortable to use as pen and paper."
By doing so, they reasoned, "we would have an application the end-user would want to use." The result was Rave, now in version 5.2. Version 5.4, currently in beta testing and due out this summer, expects to be able to handle every clinical trial and every patient a company tracks, anywhere in the world.
ClinPhone is among the e-trial leaders with an extensive set of software tools. The firm recently web-enabled its Clinical Trial Management System, TrialWorks, which both streamlines access and allows remote access. "This allows a monitor to take a local copy and synchronize it back at the office," according to Dr. Byrom.
He emphasizes, however, that this is only one piece of a comprehensive e-clinical trials system. As his U.S. counterpart, Dave Stein, elaborates, from electronic data capture data still must be aggregated and analyzed and entered into disparate systems.
"Sponsors still need a clinical data management system. Some vendors are building tools into their EDC (electronic data capture) systems to eliminate the need for a back-end database," but trials management involves a host of such administrative details as tracking patient visits and making investigator payments based upon that, as well.
Furthermore, when a patient is enrolled in a trial, a variety of systems need to know about it, he says. Using ClinPhone's Connect for EDC Systems, data is entered once and then automatically populates the necessary systems with that information.
"This eliminates duplication of data and activities, for example, during the randomization or enrollment stages, which, in an un-integrated environment would require similar data to be entered into both EDC and IVT systems," Dr. Byrom says. "Integration has the benefit of not asking the investigator to do things twice."
Despite the growing interest in software suites, most of the e-clinical trials offerings are still point solutions. The front endpatient diariesaren't necessarily included in the emerging software suites.
"Pharmaceutical companies prefer to use best of breed solutions and expect the providers to solve the interoperability problems," says Doug Engfer, co-founder, president and CEO of Invivodata (www.invivodata.com). Electronic patient diaries are one of the applications designed to integrate seamlessly with existing clinical trial processes.
"They are the one piece of the electronic clinical trials puzzle that focuses solely on the patient," he says, "and puts the data in the context of the way they live their lives. Patient-reported data is used by 75 percent of all clinical trials and are a key aspect in understanding if a drug is safe and effective."
He continues, "Our recent NDA approvals, including Amylin Pharmaceuticals' Symlin and Allergan's Acular LS, are testimonies that this technology is ready for prime time."
Historically, patient compliance with diary protocol has been a challenge. A study conducted by Arthur Stone, Ph.D., and colleagues at State University of New York at Stony Brook, found that 89% of all paper diaries were either back-or forward-filled by patients, rather than being completed at the scheduled time.
With real-world clinical studies using Invivodata's Palm-based electronic diary, DiaryPRO, however, compliance consistently reached 93%.
"The key," according to Michael Hufford, Ph.D., Invivodata's vp, scientific affairs, "is outstanding subject training that makes sure patients fully understand what's expected and how to use the technology, an easy user interface, easier than an ATM, with a proprietary compliance system with on-screen reminders if the patient is off track.
"It also can issue e-mail to alert the trial site and collect real-time data about how the patient is doing," both in terms of compliance and adverse events.
The data itself drops into drug and device development programs seamlessly, without the changes to work processes that plague many other software applications.
Dr. Hufford adds that patient groups have said they get a feeling of value and importance because the sponsor has invested in them, by providing a PDA for them for the trials.