By Amanda Fox
April 15, 2003 | As the pressure rises to compress the time it takes to conduct clinical trials, commercial and research institutions alike are adopting electronic data capture (EDC) to improve clinical trial management. Recently, Biogen and Dana Farber/Partners CancerCare (DF/PCC) have gotten in on the action, demonstrating that EDC applies to both settings.
With an increasing number of federal clinical trial and drug development regulations to meet, just having the data isn’t enough. Drug developers need all the information about the information and immediate access to it. EDC leverages computers and the Internet to collect and manage clinical trial data, offering real-time access to cleaner data. Using EDC, a doctor can enter patient information collected during an office visit into a computer, which then transfers it directly into a database. By reducing or eliminating the lengthy practice of mailing collected data to clinical trial sponsors for data entry before analysis, sponsors can address questions or discrepancies immediately, improving the overall decision-making process, as well as patient safety.
As the oldest independent biotechnology company, Biogen is heavily invested in paper-based drug trials. About 18 months ago, Biogen began the search for an EDC solution, enlisting the help of technology consultancy Accenture in the process.
“We put together a core team and came up with a list of Biogen requirements for EDC tools. [Then], we matched it up against what the vendors had to offer,” says Bina Keshavan, EDC program manager at Biogen. After considering a number of different products, Biogen ultimately selected InForm, the Internet-based EDC software platform from Phase Forward.
Following an initial trial period, Biogen -- already a longtime user of Phase Forward's Clintrace safety reporting system and Clintrial clinical data management software -- signed a three-year global technology subscription agreement with Phase Forward last September for InForm, which it plans to implement across selected Phase II and Phase III global clinical programs. “We’re moving forward with using EDC as our default method of data capture,” says Jack Gulinello, director of clinical data management at Biogen.
According to Keshavan, several trials are up and running in the application service provider (ASP) mode, which puts design, server hosting, and help-desk functions in the hands of Phase Forward, freeing Biogen to focus on trial execution. It’s still too early to tell, though, what the time and cost savings will be with the new system. Biogen is currently bringing the technology in-house. “With the technology trial, we have internalized design and we are in the midst of doing our first of several [drug] trials using [EDC],” Keshavan says.
“They’re going through the training. They’re going through the installations,” says Mike Davies, eastern region sales manager at Phase Forward. The typical InForm implementation takes two to 12 weeks. “The variability is often the sponsor company themselves understanding how they’re going to take advantage of the technology in-house,” explains Rick Friedman, director of product marketing at Phase Forward.
Trials and Tribulations
Phase Forward has implemented about 270 clinical trials using EDC, according to Friedman, who says his company is the number 1 supplier of EDC solutions to the drug industry. But the company acknowledges that the EDC market is evolving.
“There’s been a need within the industry that we’ve discovered to integrate the EDC system and the back-end clinical data management system,” Davies says. “There are benefits to companies that do this because they can realize economies of scale in terms of trial design [by using] the same database to develop electronic trials or paper trials, or even to combine them in a hybrid trial.”
DF/PCC, which includes Dana-Farber Cancer Research Institute, Brigham and Women’s Hospital, and Massachusetts General Hospital, is among the companies looking for something more. According to Elizabeth McColligan, team leader for the clinical trials information systems group at DF/PCC, the goal was to find a system not only for EDC but also to manage the trial conduct and performance of adult clinical trials. After an intensive review of the market, the company settled on eResearch Technology’s (eRT) eResearch Network.
“[ERT] was also interested in working with us to expand the functionality from an academic medical center point of view,” McColligan says. “Most of these [EDC/clinical trial management] products have really been developed for a big pharmaceutical company or a clinical research organization where the needs are slightly different.” DF/PCC is the fourth oncology research center in the past year that has contracted to use eRT’s product.
“From a clinical perspective, nothing’s going to change,” McColligan says. The system is designed to help the data management staff coordinate with the clinical staff and to help the physician-investigators review adverse events as well as complete preliminary data analysis of trials and cross-trials.
Long term, DF/PCC would like to have a feed into an order-entry system where clinicians could order appropriate clinical activities for a particular patient, such as a blood-glucose-level test for a diabetic, McColligan says. “We’re looking for something that will help us drive the performance of the trials. We know what data need to be collected on certain days. So, how do we get those things ordered so they get collected in a timely fashion? We would like to take the case report forms and turn them into worklists. I’m not convinced that that’s doable right off the bat, but that’s the kind of thing that we’re looking to try.”