A Patient Universe

May 1, 2010

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-05-01-2010, Volume 0, Issue 0

Integration of EHR-EDC data could chang the way clinical research approaches subject recruitment

There has been a tremendous surge of recent activity concerning the integration of electronic health record (EHR) systems with electronic data capture (EDC) systems. Although the marriage of these two disparate sources of data may yet be some years away—and significant obstacles still remain—numerous pilot programs from both the health care and biopharmaceutical industries suggest that this potential linkage can not only be accomplished, but that immeasurable benefits for all stakeholders can be had in doing so.

Linking EHR with EDC could potentially make the identification of safety trends easier to determine. A major problem with today's trial data collection practices is that all of the critical information is housed separately, as most sponsors have a variety of systems in place to look at data on an ongoing basis. But in most cases, one set of people looks at adverse event data, another at lab data, and yet another at serious adverse event data. Many companies have processes and tools to look across all of these data sets within one patient, but they are not able to systematically and comprehensively observe across all of these sources of data, and across all of their patients in real time. Furthermore, most companies aren't reconciling these data until the end of a study, which hinders the possibility of conducting trending analysis to identify potential safety concerns.

In an ideal scenario, all of the data would be available in one system within 24 hours of the patient's visit. This would enable a physician to identify possible safety concerns as they materialize, even in a global study with thousands of patients and hundreds of sites.

Interconnected health and research data could also provide clinical researchers with a comprehensive view of the patient universe. Armed with a robust understanding of the patient population, clinical researchers could streamline many aspects of the recruitment process, including trial feasibility, protocol design, site selection, and patient referral. Potentially, such data could even reduce the number of trials and patients required to test new medicines and increase the speed it takes to develop a new therapeutic.

Identifying sites with a large number of potentially eligible patients also is paramount, as is selecting quality sites that meet recruitment goals on time and execute the protocol successfully. By combining patient data with historical site performance data, it could be possible to select the right sites for the right protocol, and thereby decrease the time it takes to launch a new study.

Innovative companies are already integrating data to increase the speed, number, and quality of patients recruited for trials. But as an industry we must collaborate on a greater scale to realize the full potential that all of these data sources hold. We must work with government, technology providers, patients, payers, and health care providers to encourage the responsible use of electronic health data to advance clinical research and serve tomorrow's patients.

Christopher Cabell, MD, MHS, FACC, is Senior Vice President, Access to Patients, at Quintiles. He can be reached at [email protected].

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