Unraveling the eSource

Industry-wide standards for electronic patient data have long felt like buried treasure. Companies today are getting closer—by way of a tangled map.
Nov 01, 2006

It's easy to imagine a not-too-distant future when electronic health records (EHR) and electronic medical records (EMR) are an essential part of patient care.

In this future, doctors working in clinics, hospitals, and private practices work with computers, PDAs, or other devices to retrieve and enter information about their patients, whose records are updated in real-time.

Learn the Lingo
On the pharma side, EHRs streamline the clinical trial process. Sponsors, for example, are able to tap into a national e-health system and identify investigators with appropriate patient pools. They're also able to more quickly develop the necessary clinical trial infrastructure—protocols, data-capture systems, and databases—by using computerized tools, electronic communication, and libraries of standard data elements and edit checks.

The vision is that one day there will be industry-wide standards for EHRs. This will increase efficiencies by enabling sponsors to deploy clinical studies to trial sites in the form of independent software modules. Because the clinical modules will run on investigator sites' own EHR systems, they will look and feel familiar to physicians—sharply reducing training time.

Industry-wide standards will also allow an exchange of information between clinical researchers and providers of patient care. Physicians, as they enter information about an individual patient visit, will be informed if that patient is enrolled in a clinical trial, prompting them to collect additional information or assist them with scheduling and patient-visit reminders. At the same time, if a physician keys in wrong information—say, a prescription that is contraindicated for a particular patient—the system will send out a notification, helping to prevent medical errors.

Rewind to present day: The healthcare system and the pharmaceutical industry are just beginning to move toward using information technology in such a way that could make this scenario possible. But some substantial obstacles—rooted in the very nature of patient care and clinical trials—stand in the way. It is important for both healthcare and pharma leaders to understand the nature of the problems; if they can be solved, patients, physicians, and pharmaceutical companies all stand to gain substantial benefits.

The (Unrealized) EDC Dream

Adoption of EMRs in hospitals and private practice is on a steady incline, driven by the need to manage costs and deliver higher-quality healthcare while enhancing the safety of patients. Reports from 2002 (the last year data were collected) suggest that 20 to 25 percent of US healthcare practices, and close to 50 percent of hospitals, use EMR/EHR systems.

The European Divide
In Europe, there is great variation between countries: EMR use is as high as 90 percent or more in the Scandinavian countries, while less than 20 percent in some others (see "The European Divide").

At the same time, clinical trial sponsors are increasingly using electronic data capture (EDC) systems, which hold the potential to dramatically reduce the time and effort needed to acquire and process clinical trial data. Today, an estimated 27 to 30 percent of clinical trials in both hospitals and private practices use EDC.

Going forward, those systems will be particularly valuable to pharma if they can be used to populate EDC systems.To understand the problems associated with integrating EHRs and clinical trials, however, it is essential to focus on the concept of "source data," which lies at the heart of data collection and management for all clinical trials.

The ICH Harmonised Tripartite Guideline for Good Clinical Practice defines source data as all information in original records and certified copies of original records of clinical findings, observations, or other activities necessary for the reconstruction and evaluation of a clinical trial. Source data are contained in source documents, which include hospital records, patient charts, laboratory notes, and pharmacy dispensing records.

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