Merger of EDC and EHR The Electronic Health Record (EHR) is defined as a patient central information resource for clinicians—a "secure, real-time,
and point-of-care patient centric information resource for clinicians."6 It should aid in the decision making of physicians by incorporating evidence-based information and by providing access to
a complete set of patient health records. It also helps with the collection of data for billing, disease management, and resource
planning. The idea to use EDC in health care is not new. Efforts to develop EHRs have been made in many parts of the world
for many years,7 and there is still a global trend toward the use information technology in health care. It is well known that clinical research also can benefit from EHRs. The main advantage of having only one database for normal
patient care activities and clinical research is obvious: Data would be entered only once and could then be available for
both. The elimination of double data entry on site could improve efficiency enormously. There would be fewer errors from data
transcription and the costly and time-consuming process of source data verification could be avoided. Moreover, this would
offer the potential for real-time response to possible adverse reactions and could finally speed up the process of clinical
trials.8 Reality, indeed, is still different. Most of the existing EHR systems cannot be used directly as a source for clinical research
data. There are two main reasons for that: the variability of systems and data documentation, and the fact that most of the
EHR systems are not in line with existing clinical research regulations9 (e.g., FDA regulation 21 CFR Part 11). Despite obvious advantages, there is one important prerequisite for the merger of
EDC and EHR: standardization. The same "language" has to be used in both systems to enable users to share, review, sort, and
analyze the data. Currently, there are two main standard setting bodies in this area: the Clinical Data Interchange Standards
Consortium (CDISC)10 for research data standards and Health Level 7 (HL7)11 for health care data. The main aim of both standard setting organizations is to contribute to an environment where one electronic source can be
used for clinical research, medical care, and regulatory authorities, which makes data entry technologies like EDC useless
at the end of the day. But how long will it take until EDC in clinical trials becomes unnecessary? According to a December
2006 Applied Clinical Trials online survey,12 70% of total responders (375) agreed or strongly agreed that EDC and EHR will merge within the next five years. This figure
shows that more and more clinical trial professionals believe that this scenario will become true soon. This belief in a short-term
change in technology has been here before. In the early 1990s, the first steps toward the use of EDC systems were made. Elke Jahn,* MSc, is group manager, clinical research & medical information, Berlin-Chemie AG, Glienicker Weg 125, 12489 Berlin, Germany,
email: ejahn@berlin-chemie.de
Johann Pröve, MD, is global head, data management, Bayer Schering Pharma. *To whom all correspondence should be addressed.
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