Contributed Commentary by Jim Rogers

November 9, 2015 | There’s been a lot of talk within the industry about how integrating electronic data capture (EDC) platforms used within the clinical research industry with platforms used to create, manage and store electronic health records (EHR) could benefit physicians, healthcare institutions and pharmaceutical companies. But there is an additional benefit that directly impacts improvements in patient safety that has been less noticed: how EDC/EHR integration can actually make existing drugs, therapeutics and medical devices safer for patients.

By integrating clinical research data tools with EHRs, significant improvements can be realized in the process for reporting serious adverse events caused by treatments that have already completed the regulatory approval process. Since it is not possible to fully identify all potential health hazards in controlled clinical trials (due to the relatively small numbers of patients), pharmaceutical companies rely on post-marketing pharmacovigilance and post-marketing studies to continuously update the safety profile of a product.

Since pharmacovigilance investigations can be both costly and time-consuming, they are not undertaken lightly; however, much of the patient data needed for safety reporting is already captured in EHRs. If that information could easily be leveraged by clinical researchers, and more easily reported by physicians, the costs and timelines for safety reporting and studies could be significantly improved—and this is exactly what an integrated EDC/EHR platform can facilitate.

In 2008-2009, a seminal project named ASTER (ADE Spontaneous Triggered Electronic Reports) was initiated by Pfizer with Boston’s Brigham and Women’s Hospital, Boston’s healthcare system Partners Healthcare, data standards organization CDISC and nonprofit CRIX International. It served as a proof-of-concept study to demonstrate a new methodology for gathering and reporting spontaneous adverse drug events (ADE).

ASTER implemented automated ADE collection in an ambulatory clinic’s electronic health record system using the flexible standard for data collection known as “Retrieve Form for Data Capture” (RFD) designed by CDISC and Integrating the Healthcare Enterprise (IHE). CRIX International hosted the application, which allowed direct downloading of data from the EHR and direct submission to the FDA in the proper formats for electronic reporting of individual case safety reports (ICSRs).

Here are just a few of the study’s findings:

• For physicians, the time it took to complete a safety report went from 36 minutes (the estimate to complete the online MedWatch form, which is the FDA’s standard safety reporting form) to less than one minute—accomplished by capturing data directly from the EHR.
• Even though most participating physicians (91%) had not submitted a single safety report the prior year, after enrollment in the study, they submitted an average of five reports per physician in a three month period, with all physicians submitting at least one report
• The time it took for a physician to identify a possible adverse event, until the time that report was sent electronically to FDA, was an average of 20 minutes.

The study’s conclusion: an integrated EDC/EHR platform, if implemented across a large site network, could provide powerful post-marketing safety data for regulators and sponsors. ASTER clearly demonstrated the power of digitized healthcare data.

Fast forward from 2009 to 2015. Despite all of the benefits demonstrated in the ASTER study for how better information on the safety of drugs could be collected and disseminated, the adoption of integrated EDC/EHR is still in its infancy. Worse, despite meaningful use incentives, full EHR adoption by the healthcare industry has yet to take place.

Why? I asked Michael Ibara, who served as the ASTER study director for Pfizer and is now the Head of Digital Healthcare for CDISC.

“When it comes to EHRs and adoption of new ways to improve safety, the issue is with the healthcare enterprise itself,” he told me. “It’s the most complex human-made network on the planet. There are just so many stakeholders and components, it’s difficult to get everyone on the same page.”

As for the U.S Food and Drug Administration (FDA) and the pharmaceutical industry’s response to novel adverse event reporting methods, “Incentives have been misaligned,” he observed. “There has been little incentive to change economically or in a regulatory sense. The last major review of the concepts that form the foundation of post-marketing safety collection and reporting was at the the time of the release of the MedWatch form, which happened the same year as the debut of the World Wide Web.”

Ibara believes we need to have a broader discussion on what constitutes drug safety, now that Internet-based technologies are available. The catalyst for change—EDC/EHR integration—is in place, with its ability to make adverse event reporting easier for physicians to do. But Ibara thinks that it will take a new directive to make it happen, which might take the form of gradual incentives through the healthcare system.

“If we wait too long, someone will realize the value of using digitized healthcare data to leapfrog the way drug safety information is collected and analyzed, and will create a company to do it,” he theorized. “What is needed now is work on aligning the incentives, economics, regulatory issues, and outcomes to make it desirable for EHRs, sponsors and regulators to take full advantage of the digitized data that’s already sitting there. Then, maybe the pieces will come together so that physicians willingly report adverse drug affects in patients outside of ongoing pharmacovigilance studies, giving us a larger pool of safety data. We, as the public, will certainly benefit from that.”

Jim Rogers leads Nextrials’ executive team by providing strategic vision and coordinating the activities of the company’s operations, clinical services and IT departments. He can be reached at jrogers@nextrials.com.