Streamlining Safety Data
by Mary Sgammato
July 2008
With electronic data collection becoming more mainstream, clinical trialists are now looking to incorporate safety data into the electronic mix as well.
The increasing adoption of electronic data collection (EDC) in clinical trials is a reflection of trial sponsors’ growing comfort with and understanding of the benefits of technology-enabled clinical trial data management. As the pharmaceutical industry continues to transition away from studies that rely principally on paper-based data collection and reporting, the advantages and efficiencies of EDC continue to become increasingly apparent. Many of the early challenges that some feared might relegate this technology to obsolescence before it could prove its benefits seem to have been overcome as EDC increasingly becomes the process of choice for investigators and sponsors.
One important area in which paper remains the reporting vehicle of choice is in capturing and reporting serious adverse event (SAE) data. While the industry continues to resolve early growing pains associated with the adoption of EDC with the move toward a standard electronic common technical document (e-CTD) format, reporting of adverse events appears to remain stubbornly paper-based.
“SAE data is still captured on paper in the majority of trials,” says Alex O’Toole, senior director and global head of EDC for Quintiles in London. According to O’Toole, investigators are more inclined to use the traditional method of faxing adverse event reports to pharmacovigilance groups because of the seriousness of the data and the 24-hour reporting requirement. There is such a great emphasis on safety in this industry that adverse event reporting is one of the last processes to make the move over to electronic processes, and paper remains the norm, at least for now. As a result, using EDC systems to report SAEs is widely perceived as a duplication of effort, but O’Toole says he’s confident that electronic reporting will be more widely adopted as the industry becomes more convinced of its benefits.
A Case for Change
At Bayer HealthCare, the company’s early EDC systems did not include a built-in SAE reporting feature, says Dr. Uwe Barlage, EDC project leader at Bayer, in Leverkusen, Germany. Instead, Bayer relies on a separate, paper-based process for safety information, which requires reconciliation of both databases—study and pharmacovigilance—at the end of a study.
Bayer is preparing to conduct a pilot study to test a process using EDC for SAE reports, Barlage says, noting that the results of the pilot program will determine the course for the future. Other industry sponsors likely will follow a similarly conservative route in collecting safety information for now, he says.
“I am not aware that other companies are already following this path to a greater extent,” he says. “I have not heard of other companies using [EDC] as their main reporting route.” Many companies have not yet made the move to exclusive use of EDC for clinical trial data capture, he says.
Just as industry sponsors needed to be convinced of the benefits of EDC over in-house or other approaches, demonstrating the benefits of EDC in capturing SAEs is needed before this becomes standard industry practice. O’Toole says the benefits are sufficiently clear and compelling, and that the ease and simplicity of electronic reporting will make a strong case for adoption of EDC for SAE capture and reporting.
“EDC systems can have built-in minimum data checks to ensure the data required by regulatory authorities are provided,” O’Toole says. “When site investigators and coordinators send in SAE reports via fax, they need to wait to confirm that the report has been received and are often notified that the data are incomplete.” With EDC, investigators can be confident that their reports have been properly filed and submitted, he says. “We cannot build interactive checks into a fax machine.”
Widespread Potential
Capturing safety data electronically is the first step to improving the way safety data are captured and reported, O’Toole says. “The ability to then analyze the data across sites within a study would be a second step, and the third step would be allowing analytics to be performed across studies.”
“There is a tremendous emphasis on safety within our industry,” he says. EDC has the ability to quickly and efficiently report patient safety data and mine the data across trial sites and studies to detect potential safety issues, he adds.
The pharmaceutical industry has widely adopted EDC because it has been convinced of the benefits, in terms of efficiency, access to data, ease of reporting and analysis and simplicity of use. Demonstrating the value of EDC over paper-based methods in capturing and reporting on SAE data is the next challenge posed by an industry in which safety is paramount. This emphasis on safety is, paradoxically, both the incentive for continuing with established and traditional paper-based approaches and the argument for adopting technology-enabled reporting methods.
An Industry Challenge
Using EDC to capture and report on serious adverse events is a focus of the e-Clinical Forum, a not-for-profit pharmaceutical industry group with interlinked branches in Europe and the United States. The Forum, which pharmaceutical industry representatives formed in 2000, is comprised of members with varying degrees of experience with EDC. According to Selina Sibbald, Quintiles’ director of global EDC systems in Edinburgh, Scotland, and a member of the Forum, there is “huge interest” in simplifying and streamlining the SAE capture and reporting process.
“Although EDC is not yet widely used for SAE reporting, many companies want to move in this direction,” Sibbald says. “But very few have taken the plunge. This is a complex issue, and people in our industry are naturally wary of risk when it comes to such important data. Our members are looking for a single core process that will allow investigators to enter data once and use it in multiple ways,” she says, adding that eliminating redundancy is another key goal of the group.
Over the past few months, members of the e-Clinical Forum have gathered information on the varying approaches the industry is taking to capture SAE data and are developing recommendations for a uniform reporting process. Regulators have taken a hands-off approach regarding the process, leaving it up to the industry to develop processes that work best. “As long as investigators and responsible companies comply with requirements for timeliness and accuracy of SAE reporting,” Sibbald says, “regulators don’t seem to mind what methods are used.”
The Forum now is analyzing information collected from its members and will issue a white paper on this topic later this year.
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