The U.S. Food and Drug Administration (FDA) has formally announced that it is interested in supporting the use of electronic health records (EHR) used in conjunction with electronic data capture (EDC) technology in clinical trials to streamline the drug discovery process. After posting a notice in the Federal Registry, the FDA’s Center for Drug Evaluation and Research (CEDR) commented that a standards-based, integrated solution could not only facilitate quicker study starts by identifying and enrolling qualified patients, it could significantly streamline data collection and make it easier for the FDA to inspect it.
Integrated EDC/EHR is not a new concept; the industry has been actively promoting it since 2008. Since the process and data collected are so similar, an integrated EDC/EHR platform could simultaneously be used in both patient care and clinical trial settings. To that end, demonstrations of interoperability exploring this viability have been sponsored by organizations such as Integrating the Healthcare Enterprise (IHE), the Healthcare Information and Management Systems Society (HIMSS), Clinical Data Interchange Standards Consortium (CDISC) and the Drug Information Association (DIA).
From as early as 2011, the FDA has even participated in or attended various interoperability showcases. Still, since government agencies are rarely thought of as nimble thought leaders driving innovation, this now formal declaration of support for the merits of EDC/EHR integration is noteworthy.
It’s no secret that the government has a keen interest in reducing the cost of developing new therapeutics as part of an overall plan to make healthcare more affordable. Given that, perhaps it’s not so surprising that the FDA is taking a closer look at any solution that could be used to accelerate data collection without compromising quality and patient safety. Currently, the FDA’s Priority Review process for new pharmaceuticals is approximately six months; Standard Reviews are even longer at 10 months.
EDC platforms that traditionally are used for clinical trials have many of the same functions as EHRs, resulting in a myriad of ways that data duplication could be eliminated — thereby reducing drug development costs. As a specific example, because 80 to 90 percent of the data in a clinical trial is taken directly from a patient’s record, an integrated platform offers faster data collection and significantly reduces source data verification.
Prior to its formal announcement, members of the FDA had already been taking a harder look at EDC/EHR integration and how the technology could facilitate an easier review process within the agency. Nextrials had previously collaborated with the FDA and other companies to help develop integration standards, and was recently invited to stage a live demonstration of its EHR integration tool (E2E) for the CDER Healthcare IT Group and the authors of the FDA’s eSource Guidance. This forum facilitated a productive discussion of how patient data collected directly from his or her EHR record can improve data quality and streamline drug safety reporting.
As the FDA continues to demonstrate its support for EDC/EHR integration and the efficiencies it could provide, the industry will follow suit. In 2009, one of the first multi-site studies to use an integrated platform was facilitated by Nextrials and Greenway Health. Fast forward to 2015, and there are already a number of biotech and pharmaceutical companies actively planning study protocols that use an integrated EDC/EHR platform. Hopefully, this trend will continue, as streamlined data processes can not only help in the FDA review process, they can reduce study costs — and most importantly, give patients broader access to clinical trials.
Jim Rogers is CEO at Nextrials.
