A Work in Progress
by Mary Sgammato
April 2007
Electronic data capture must address the reality of field-based data collection before it can become an industry standard.
Bringing a new pharmaceutical product to market is a lengthy and expensive process. Because clinical trials account for the bulk of the time and cost involved in drug development, trial sponsors must optimize resources and increase productivity in this critical phase. With an electronic data capture (EDC) system, enormous efficiencies can be achieved in terms of site monitoring and reducing the amount of paperwork, particularly in Phase III trials that may involve hundreds of sites and thousands of patients.
In comparison to traditional paper-based data collection, EDC potentially can reduce costs, save time and enable better analysis of clean data throughout the drug development process. But universal adoption of EDC by trial sponsors has yet to occur, and it will take more time for the reality of field-based data collection to catch up with the tremendous potential and promise offered by EDC.
Technology vs. Reality
Seasoned trial coordinators are cautiously optimistic about the benefits and potential of EDC systems. Judith Spilker, neurovascular research coordinator at the University of Cincinnati College of Medicine, in Cincinnati, Ohio, USA, has coordinated more than 20 acute stroke research trials over the past 25 years and says she believes the field is moving in the right direction. “There have been real improvements in the [EDC] systems over the past few years,” she says. “The newer, Internet-based systems are much more flexible. There were a lot of complaints about the earlier versions.”
However, Spilker does question the practical challenges of operationalizing EDC across multiple trial sites. For example, in systems without fully computerized medical records, it often is difficult to extract research data from an active hospital chart, particularly in acute treatment clinical trials. Spilker also notes that none of her system’s community-based sub-site hospitals have fully computerized medical records. This is of particular concern when trial coordinators are faced with the stringent data-collection and data-entry time requirements of EDC systems. “There should be no less time allowed for data collection and data entry than there is for paper record completion,” Spilker says.
Even Internet-based EDC systems, which allow for easier access and more flexibility, present challenges for trial coordinators. The care-giving environment is not always computer-friendly, and medical records departments generally don’t have Internet access, Spilker says. The ideal scenario for hospital-based trials is computerized medical records and Internet access, she says.
Even then, redundancy of data entry is another challenge for investigators. Dr. Mitzi Marie Chua, senior fellow of infectious diseases at the University of Philippines-Philippine General Hospital, in Manila, is currently a sub-investigator on a three-year, three-site trial. “We have to enter the data twice,” Chua says. “Once on paper and once on the computer. If we could do away with paper files, we could eliminate duplication and save time for data input as well.”
Chua is generally very positive about the system used for her current trial, but she suggests minor revisions. For example, complete data on medications must be entered each time it is dispensed, rather than once per day, to show that day’s dosage. Chua also recommends that EDC systems use wireless Internet access capabilities. “It’s much more reliable than cable, especially if there is an earthquake,” she says, citing an example of a recent earthquake in Taiwan that resulted in destruction of the underwater cable wires that supply Internet service to the Philippines.
Cleaner Data
Although EDC can resolve many data issues up front by programming range and logic checks to the data entry interface, it is by no means a one-size-fits-all approach, says Yuko Palesch, Ph.D., director of the data coordination unit in the department of biostatistics, bioinformatics and epidemiology at the Medical University of South Carolina, in Charleston, S.C., USA. Palesch has provided data management to four clinical trials over the past three years using a “home-grown” EDC system developed by her group. She sees numerous benefits in terms of efficiency and data cleanliness. However, these benefits are due in large part to the significant time programmers have spent creating range and logic checks for each study, she says. For trials of the same or similar clinical conditions, such as the several ischemic stroke studies conducted by her center, there is an economy of scale in creating the study databases, because the same rules apply to the common data items, Palesch says. But a study in a different clinical area requires considerable up-front programming time that must be taken into account when evaluating the costs of conducting a trial.
Palesch remains a strong proponent of EDC, even while acknowledging some of the challenges it presents, such as site study coordinators’ additional time and effort to enter data into electronic databases. “Although EDC is the ideal, a completely paperless study is far from reality,” she says. This is particularly true in neurological emergency trials, in which coordinators usually obtain data in emergency rooms and may not have time to log in to the Web site to enter the data while assisting with patient care and making clinical assessments for the study. There also is the challenge of timeliness of data entry, which is critical to expedite and facilitate monitoring for safety and study progress.
As with the introduction of any new system, the implementation of EDC is far from perfect. The potential savings in both time and money may not be too difficult to obtain, but incorporating early feedback from investigators and trial coordinators will ensure that the trend toward a paperless data collection continues in earnest.
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